{"id":28931,"date":"2023-06-15T17:03:38","date_gmt":"2023-06-15T15:03:38","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=28931"},"modified":"2024-06-11T12:42:00","modified_gmt":"2024-06-11T10:42:00","slug":"template","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/template\/","title":{"rendered":"Template"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-padding-bottom:0px;--awb-background-color:#ffffff;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-font-size:20px;\"><p>Over the years, experience and practical application have led <strong style=\"color: var(--awb-color5);\">THEMA<\/strong> to develop <strong>documents, support materials<\/strong> <strong>and<\/strong> <strong>content<\/strong> to help medical organisations implement regulatory requirements. Speed up the compliance process with <strong>templates and checklists<\/strong> on quality management system and regulatory activities in different countries, written by <strong style=\"color: var(--awb-color5);\">THEMA<\/strong> experts and validated by an incredible number of uses and checks.<\/p>\n<p style=\"color: var(--awb-custom12);\"><b style=\"color: var(--awb-color5);\">Choose the right document for you.<\/b><\/p>\n<\/div><form  class=\"is-search-form is-form-style is-form-style-1 is-form-id-29887 \" action=\"https:\/\/www.thema-med.com\/en\/\" method=\"get\" role=\"search\" ><label for=\"is-search-input-29887\"><span class=\"is-screen-reader-text\">Search for:<\/span><input  type=\"search\" id=\"is-search-input-29887\" name=\"s\" value=\"\" class=\"is-search-input\" placeholder=\"Search by Keyword ...\" autocomplete=off \/><\/label><input type=\"submit\" value=\"Search\" class=\"is-search-submit\" \/><input type=\"hidden\" name=\"id\" value=\"29887\" \/><input type=\"hidden\" name=\"post_type\" value=\"page\" \/><\/form><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-0 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"Checklist_USA\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA-300x150.png\" alt class=\"img-responsive wp-image-28616\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-1 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Checklist 21CFR 11<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=28548\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-1 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-2 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-2 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"Checklist_USA\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA-300x150.png\" alt class=\"img-responsive wp-image-28616\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-2 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Checklist prescreening 510(k)<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-2 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=28655\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-3 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-3 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-4 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-3 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"Checklist_CAN\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_CAN-300x150.png\" alt class=\"img-responsive wp-image-28635\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_CAN-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_CAN-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_CAN.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-3 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Checklist prescreening MDL<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-3 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=28662\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-5 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-4 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-6 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-4 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"Checklist_USA\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA-300x150.png\" alt class=\"img-responsive wp-image-28616\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Checklist_USA.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-4 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>Checklist UDI<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-4 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=28668\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-7 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-5 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-8 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-5 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-300x150.png\" alt class=\"img-responsive wp-image-28694\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-5 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Clinical Evaluation Plan (CEP) module<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-5 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=28742\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-9 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-6 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-6 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-10 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-6 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_AUS\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_AUS-300x150.png\" alt class=\"img-responsive wp-image-28907\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_AUS-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_AUS-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_AUS.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-6 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Essential requirements table &#8211; Australia<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-6 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=28905\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-11 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-7 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-7 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-12 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-7 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_BRA\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_BRA-300x150.png\" alt class=\"img-responsive wp-image-28916\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_BRA-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_BRA-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_BRA.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-7 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Essential requirements table &#8211; Brazil<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-7 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29036\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-13 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-8 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-8 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-14 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-8 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_CAN\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_CAN-300x150.png\" alt class=\"img-responsive wp-image-28923\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_CAN-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_CAN-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_CAN.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-8 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Essential requirements table &#8211; Canada<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-8 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29044\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-15 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-9 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-9 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-16 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-9 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_INTER\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-300x150.png\" alt class=\"img-responsive wp-image-28721\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-9 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>IEC 62304 Software Validation Module<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-9 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29054\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-17 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-10 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-10 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-18 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-10 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"MDR_IVDR_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-300x150.png\" alt class=\"img-responsive wp-image-28675\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-10 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>IVDR Technical Documentation<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-10 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29064\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-19 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-11 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-11 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-20 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-11 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-300x150.png\" alt class=\"img-responsive wp-image-28694\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-11 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Label translation &#8211; Instruction<br \/>\n<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-11 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29072\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-21 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-12 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-12 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-22 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-12 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_INTER\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-300x150.png\" alt class=\"img-responsive wp-image-28721\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-12 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Management procedure (SOP) Clinical Evaluation<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-12 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29079\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-23 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-13 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-13 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-24 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-13 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_INTER\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-300x150.png\" alt class=\"img-responsive wp-image-28721\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-13 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>Management procedure (SOP) pre-Clinical Evaluation<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-13 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29087\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-25 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-14 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-14 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-26 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-14 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-300x150.png\" alt class=\"img-responsive wp-image-28690\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-14 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Management procedure (SOP) post-market surveillance<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-14 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29096\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-27 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-15 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-15 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-28 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-15 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_INTER\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-300x150.png\" alt class=\"img-responsive wp-image-28721\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-15 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Management procedure (SOP) Risk management ISO 14971<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-15 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29106\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-29 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-16 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-16 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-30 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-16 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"MDR_IVDR_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-300x150.png\" alt class=\"img-responsive wp-image-28675\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-16 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>MDR Technical Documentation<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-16 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29114\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-31 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-17 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-17 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-32 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-17 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_INTER\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-300x150.png\" alt class=\"img-responsive wp-image-28721\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-17 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>Note to File module<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-17 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29120\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-33 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-18 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-18 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-34 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-18 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-300x150.png\" alt class=\"img-responsive wp-image-28694\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-18 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Performance Evaluation Plan (PEP) form<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-18 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29128\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-35 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-19 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-19 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-36 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-19 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-300x150.png\" alt class=\"img-responsive wp-image-28694\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-19 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Post-market surveillance plan module (PMSP)<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-19 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29136\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-37 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-20 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-20 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-38 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-20 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-300x150.png\" alt class=\"img-responsive wp-image-28694\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-20 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Post-market Surveillance Report (PMSR) module<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-20 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29141\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-39 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-21 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-21 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-40 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-21 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"MDR_IVDR_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-300x150.png\" alt class=\"img-responsive wp-image-28675\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-21 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>PRRC Designation Letter &#8211; Authorised Representative<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-21 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29146\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-41 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-22 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-22 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-42 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-22 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"MDR_IVDR_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-300x150.png\" alt class=\"img-responsive wp-image-28675\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/MDR_IVDR_EU.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-22 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>PRRC Designation Letter &#8211; Manufacturer<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-22 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29151\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-43 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-23 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-23 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-44 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-23 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-300x150.png\" alt class=\"img-responsive wp-image-28694\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-23 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>PSUR (Periodic Safety Update Report) module<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-23 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29156\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-45 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-24 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-24 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-46 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-24 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_BRA\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_BRA-300x150.png\" alt class=\"img-responsive wp-image-28808\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_BRA-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_BRA-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_BRA.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-24 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>QTA Brazilian Registration Holder (BRH) Brazil<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-24 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29161\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-47 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-25 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-25 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-48 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-25 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_CAN\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_CAN-300x150.png\" alt class=\"img-responsive wp-image-28817\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_CAN-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_CAN-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_CAN.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-25 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>QTA Importer\/Distributor &#8211; Canada<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-25 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29166\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-49 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-26 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-26 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-50 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-26 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_USA\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_USA-300x150.png\" alt class=\"img-responsive wp-image-28554\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_USA-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_USA-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_USA.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-26 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>QTA Initial Importer<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-26 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29174\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-51 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-27 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-27 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-52 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-27 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_KOR\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_KOR-300x150.png\" alt class=\"img-responsive wp-image-28852\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_KOR-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_KOR-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_KOR.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-27 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>QTA Legal Agent &#8211; South Korea<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-27 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29176\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-53 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-28 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-28 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-54 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-28 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_CIN\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_CIN-300x150.png\" alt class=\"img-responsive wp-image-28833\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_CIN-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_CIN-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_CIN.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-28 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>QTA Legal Agent China<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-28 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29181\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-55 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-29 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-29 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-56 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-29 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_RUS\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_RUS-300x150.png\" alt class=\"img-responsive wp-image-28843\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_RUS-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_RUS-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_RUS.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-29 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>QTA Legal Agent Russia<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-29 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29186\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-57 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-30 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-30 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-58 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-30 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_GIA\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_GIA-300x150.png\" alt class=\"img-responsive wp-image-28862\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_GIA-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_GIA-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_GIA.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-30 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>QTA Marketing Authorization Holder (DMAH o MAH) Japan<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-30 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29191\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-59 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-31 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-31 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-60 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-31 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_ EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU-300x150.png\" alt class=\"img-responsive wp-image-28871\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-31 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>QTA MDR\/IVDR Authorised Representative<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-31 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29196\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-61 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-32 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-32 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-62 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-32 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_ EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU-300x150.png\" alt class=\"img-responsive wp-image-28871\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-32 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>QTA MDR\/IVDR Distributor<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-32 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29205\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-63 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-33 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-33 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-64 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-33 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_ EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU-300x150.png\" alt class=\"img-responsive wp-image-28871\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_-EU.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-33 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>QTA MDR\/IVDR Supplier<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-33 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29216\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-65 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-34 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-34 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-66 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-34 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_AUS\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_AUS-300x150.png\" alt class=\"img-responsive wp-image-28892\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_AUS-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_AUS-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_AUS.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-34 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>QTA Sponsor &#8211; Australia<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-34 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29223\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-67 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-35 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-35 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-68 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-35 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"QTA_USA\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_USA-300x150.png\" alt class=\"img-responsive wp-image-28554\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_USA-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_USA-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/QTA_USA.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-35 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>QTA US Agent USA<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-35 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29241\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-69 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-36 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-36 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-70 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-36 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_INTER\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-300x150.png\" alt class=\"img-responsive wp-image-28721\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-36 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Risk management File ISO 14971<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-36 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29281\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-71 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-37 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-37 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-72 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-37 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_EU\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-300x150.png\" alt class=\"img-responsive wp-image-28694\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_EU-1.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-37 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><p><strong>Trend Analysis Module<br \/>\n<span style=\"color: #7cb3c2;\">\u00a0.\u00a0<\/span><\/strong><\/p><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-37 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29286\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-73 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-38 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-38 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-74 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-38 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_INTER\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-300x150.png\" alt class=\"img-responsive wp-image-28721\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-38 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Usability Report Form EN 60601-1-6<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-38 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29300\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-75 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-39 fusion-text-no-margin\" style=\"--awb-content-alignment:center;--awb-font-size:17px;--awb-line-height:1.8;--awb-letter-spacing:-0.015em;--awb-text-transform:var(--awb-typography4-text-transform);--awb-text-color:#ffffff;--awb-margin-bottom:0px;--awb-text-font-family:&quot;Mulish&quot;;--awb-text-font-style:normal;--awb-text-font-weight:400;\"><p><strong>Language: EN<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-39 fusion_builder_column_1_3 1_3 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:5px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-76 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:1;--awb-z-index-hover:1;--awb-padding-top:65px;--awb-padding-right:45px;--awb-padding-bottom:65px;--awb-padding-left:45px;--awb-overflow:hidden;--awb-bg-color:#f2f2f2;--awb-bg-color-hover:#f2f2f2;--awb-bg-image:linear-gradient(180deg, rgba(66,66,66,0.5) 0%,rgba(60,122,155,0.5) 100%),url(https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg);;--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-transform:translateY(55px);--awb-transform-hover:translateY(0px);--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/501K-Regulatory-template-background.jpg\"><div class=\"fusion-image-element \" style=\"--awb-max-width:250px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-39 hover-type-none\"><img decoding=\"async\" width=\"300\" height=\"150\" title=\"SGQ_INTER\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-300x150.png\" alt class=\"img-responsive wp-image-28721\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-200x100.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER-400x200.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/SGQ_INTER.png 500w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 300px\" \/><\/span><\/div><div class=\"fusion-title title fusion-title-39 sep-underline sep-solid fusion-title-text fusion-title-size-four\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-top:35px;--awb-font-size:24px;\"><h4 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Rajdhani&quot;;font-style:normal;font-weight:600;margin:0;font-size:1em;letter-spacing:-0.015em;text-transform:var(--awb-typography1-text-transform);--fontSize:24;--minFontSize:24;line-height:1.2;\"><strong>Usability Validation Module EN 62366-1<\/strong><\/h4><\/div><div ><a class=\"fusion-button button-3d fusion-button-default-size button-custom fusion-button-default button-39 fusion-button-default-span \" style=\"--button_bevel_color:#00999a8;--button_bevel_color_hover:#0099a8;--button_accent_color:#22253d;--button_border_color:#22253d;--button_accent_hover_color:#ffffff;--button_border_hover_color:#ffffff;--button_gradient_top_color:#e8e8e8;--button_gradient_bottom_color:#e8e8e8;--button_gradient_top_color_hover:#0099a8;--button_gradient_bottom_color_hover:#0099a8;--button_text_transform:var(--awb-typography3-text-transform);--button_font_size:17px;--button_line_height:1.2;--button_typography-letter-spacing:-0.015em;--button_typography-font-family:&quot;Mulish&quot;;--button_typography-font-style:normal;--button_typography-font-weight:400;--button_margin-top:30px;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/?p=29306\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Info<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-77 fusion_builder_column_inner_1_1 1_1 fusion-flex-column\" style=\"--awb-z-index:0;--awb-z-index-hover:0;--awb-padding-top:15px;--awb-padding-bottom:18px;--awb-overflow:hidden;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-border-radius:5px 5px 5px 5px;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:25px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:25px;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-40 fusion-text-no-margin\" 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