{"id":28181,"date":"2023-06-21T14:32:21","date_gmt":"2023-06-21T12:32:21","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=28181"},"modified":"2023-06-30T09:57:36","modified_gmt":"2023-06-30T07:57:36","slug":"regtodate-regulatory-update-service","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/services\/regtodate-regulatory-update-service\/","title":{"rendered":"RegToDate &#8211; Regulatory Update Service"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container 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-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-justify-content-center 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_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.496%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:3.84%;--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-image-element \" style=\"--awb-margin-top:25px;--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=\"1024\" height=\"576\" title=\"RegtoDate\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/RegtoDate-1024x576.jpg\" alt class=\"img-responsive wp-image-28426\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/RegtoDate-200x113.jpg 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/RegtoDate-400x225.jpg 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/RegtoDate-600x338.jpg 600w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/RegtoDate-800x450.jpg 800w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/RegtoDate-1200x675.jpg 1200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/06\/RegtoDate.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 600px\" \/><\/span><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-flex-column\" style=\"--awb-padding-top:20px;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:75%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.56%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0.64%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>RegToDate is the service created by Thema to help and support Manufacturers who need to stay up-to-date on legislative, regulatory and normative changes that characterise the medical device and IVD sector at national, European and international level.<\/p>\n<p>Researching, analysing and selecting laws, standards and regulations is particularly challenging for manufacturers because it requires <strong>a lot of time<\/strong> and <strong>skilled resources<\/strong>, it must be performed on a <strong>recurring and ongoing basis<\/strong> and depends on the type of <strong>product<\/strong> and <strong>processes<\/strong> involved.<\/p>\n<p>With the RegToDate service, Thema:<\/p>\n<ul>\n<li>carries out the research, analysis and selection of measures <strong>on behalf of the manufacturer<\/strong>;<\/li>\n<li>develops the activity in a <strong>customised<\/strong> manner, taking into account the product and the organisation;<\/li>\n<li>carries out the activity in a <strong>comprehensive manner<\/strong>;<\/li>\n<li>updates the <strong>list<\/strong> of documents of external origin;<\/li>\n<li><strong>proactively<\/strong> carries out the periodic update activity.<\/li>\n<\/ul>\n<p>The service is divided into two steps: The initial update and Maintenance.<\/p>\n<p>The <strong>initial update<\/strong> includes a <strong>BASIC<\/strong> formula and a <strong>SPECIAL<\/strong> formula. The first includes <strong>checking<\/strong> the status of the technical standards in the customer list, checking for new versions and <strong>updating<\/strong> the standards in the same list, without adding new items. The second includes, in addition to the basic service, the integration with other measures such as applicable laws and guidelines.<\/p>\n<p><strong>Maintenance<\/strong> can only be carried out after the first step has been completed and requires the definition of an update <strong>frequency<\/strong> with the manufacturer. This step consists of <strong>checking<\/strong> the status of the laws, standards and guidelines in the customer list, checking if there are new revisions and updating those in the customer list, without adding new items.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 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-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-2 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-padding-top:20px;--awb-padding-bottom:20px;--awb-padding-right-small:20px;--awb-padding-left-small:20px;--awb-bg-color:var(--awb-custom12);--awb-bg-color-hover:var(--awb-custom12);--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:10px;--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-2\" style=\"--awb-content-alignment:center;--awb-text-color:var(--awb-color1);\"><p>Do you want to know more about the RegToDate service?<\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_accent_color:#ffffff;--button_accent_hover_color:var(--awb-custom12);--button_border_hover_color:var(--awb-color1);--button-border-radius-top-left:10px;--button-border-radius-top-right:10px;--button-border-radius-bottom-right:10px;--button-border-radius-bottom-left:10px;--button_gradient_top_color:var(--awb-custom12);--button_gradient_bottom_color:var(--awb-custom12);--button_gradient_top_color_hover:var(--awb-color1);--button_gradient_bottom_color_hover:var(--awb-color1);--button_text_transform:var(--awb-typography4-text-transform);--button_font_size:var(--awb-typography4-font-size);--button_line_height:var(--awb-typography4-line-height);--button_typography-letter-spacing:var(--awb-typography4-letter-spacing);--button_typography-font-family:&quot;Montserrat&quot;;--button_typography-font-style:normal;--button_typography-font-weight:700;\" target=\"_self\" href=\"https:\/\/www.thema-med.com\/en\/contact-us-2\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">CONTACT US<\/span><\/a><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":114,"featured_media":28173,"parent":9970,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-28181","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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