{"id":29106,"date":"2023-07-19T10:55:18","date_gmt":"2023-07-19T08:55:18","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=29106"},"modified":"2023-07-19T10:55:18","modified_gmt":"2023-07-19T08:55:18","slug":"management-procedure-sop-risk-management-iso-14971","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/","title":{"rendered":"Management procedure (SOP) Risk management ISO 14971"},"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-padding-top:0px;--awb-padding-bottom:50px;--awb-margin-top: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:calc( 1100px + 10px );margin-left: calc(-10px \/ 2 );margin-right: calc(-10px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-padding-right:15px;--awb-padding-left:15px;--awb-overflow:hidden;--awb-bg-color:var(--awb-color2);--awb-bg-color-hover:var(--awb-color2);--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-border-radius:4px 4px 4px 4px;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:calc( 0.02 * calc( 100% - 10px ) );--awb-margin-bottom-large:0px;--awb-spacing-left-large:calc( 0 * calc( 100% - 10px ) );--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:5px;--awb-spacing-left-medium:5px;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:5px;--awb-spacing-left-small:5px;\"><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=\"text-align:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;--awb-max-width:100%;--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-zoomin\"><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, 400px\" \/><\/span><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-margin-top:15px;--awb-margin-right:0px;--awb-margin-bottom:0px;--awb-margin-left:0px;--awb-max-width:100%;--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-zoomin\"><img decoding=\"async\" width=\"212\" height=\"300\" title=\"Modulo Risk Management File ISO 14971 &#8211; EN\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Modulo-Risk-Management-File-ISO-14971-EN-212x300.jpg\" alt class=\"img-responsive wp-image-29107\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Modulo-Risk-Management-File-ISO-14971-EN-200x283.jpg 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Modulo-Risk-Management-File-ISO-14971-EN-400x565.jpg 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2023\/07\/Modulo-Risk-Management-File-ISO-14971-EN.jpg 450w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 400px\" \/><\/span><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_2_3 2_3 fusion-flex-column\" style=\"--awb-padding-left:17px;--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:66.666666666667%;--awb-margin-top-large:17px;--awb-spacing-right-large:5px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:19.9844px;--awb-width-medium:100%;--awb-spacing-right-medium:5px;--awb-spacing-left-medium:5px;--awb-width-small:100%;--awb-spacing-right-small:5px;--awb-spacing-left-small:5px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>This document is the management procedure (SOP) that describes the risk management process that the Manufacturer must implement and maintain to collect, analyze, and evaluate hazards related to the device and its life cycle in accordance with MDR\/IVDR and international requirements.<\/p>\n<p><strong>Available Languages: English<\/strong><\/p>\n<\/div><div class=\"fusion-alert alert general alert-info fusion-alert-left awb-alert-native-link-color fusion-animated\" style=\"--awb-padding-top:25px;--awb-padding-right:5px;--awb-padding-bottom:25px;--awb-padding-left:4px;\" role=\"alert\" data-animationType=\"fadeInLeft\" data-animationDuration=\"0.3\" data-animationOffset=\"top-into-view\"><div class=\"fusion-alert-content-wrapper\"><span class=\"alert-icon\"><i class=\"awb-icon-info-circle\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-alert-content\"><em>The information contained on this page and in the documents referred to is valid and current as of 07\/17\/23. Legislative and regulatory provisions are subjec to change and updating by the Regulatory Authorities. This being said, the writer declines all responsibility for any possible lack of topicality and\/or accuracy of the information that may have occurred at the same time as or following the publication of this page and the documents referred to. <strong><a href=\"https:\/\/www.thema-med.com\/en\/disclaimer\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Disclaimer (si apre in una nuova scheda)\">Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div>\n<\/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-padding-top:0px;--awb-margin-top:0px;--awb-background-color:var(--awb-color2);--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_5 1_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:15px;--awb-spacing-right-large:9.6%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:9.6%;--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><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_3_5 3_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:60%;--awb-margin-top-large:15px;--awb-spacing-right-large:3.2%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:3.2%;--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\">\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f28983-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"28983\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/en\/wp-json\/wp\/v2\/pages\/29106#wpcf7-f28983-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"28983\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.1\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f28983-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_group_fields\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_visible_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_repeaters\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_steps\" value=\"{}\" \/><input type=\"hidden\" name=\"_wpcf7cf_options\" value=\"{&quot;form_id&quot;:28983,&quot;conditions&quot;:[],&quot;settings&quot;:{&quot;animation&quot;:&quot;yes&quot;,&quot;animation_intime&quot;:200,&quot;animation_outtime&quot;:200,&quot;conditions_ui&quot;:&quot;normal&quot;,&quot;notice_dismissed&quot;:false,&quot;notice_dismissed_update-cf7-6.1.1&quot;:true}}\" \/><input type=\"hidden\" name=\"_wpcf7dtx_version\" value=\"5.0.3\" \/><input type=\"hidden\" name=\"_wpcf7_recaptcha_response\" value=\"\" \/>\n<\/fieldset>\n<h3>Would you like to buy this template?\n<\/h3>\n<h5>Fill in the form and you will be contacted by our Customer Service for a no-obligation quote.\n<\/h5>\n<p><label><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"Email\" type=\"email\" name=\"your-email\" \/><\/span> <\/label><br \/>\n<label><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"your-name\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"Name\" type=\"text\" name=\"your-name\" \/><\/span> <\/label><br \/>\n<label><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"your-surname\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"Surname\" type=\"text\" name=\"your-surname\" \/><\/span> <\/label><br \/>\n<label><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"your-company\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"Company\" type=\"text\" name=\"your-company\" \/><\/span> <\/label><br \/>\n<label>Country of your company<br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"Country\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"Country\"><option value=\"\">&#8212;Please choose an option&#8212;<\/option><option value=\"Afghanistan\">Afghanistan<\/option><option value=\"Albania\">Albania<\/option><option value=\"Algeria\">Algeria<\/option><option value=\"Angola\">Angola<\/option><option value=\"Argentina\">Argentina<\/option><option value=\"Armenia\">Armenia<\/option><option value=\"Australia\">Australia<\/option><option value=\"Austria\">Austria<\/option><option value=\"Azerbaijan\">Azerbaijan<\/option><option value=\"Bahrain\">Bahrain<\/option><option value=\"Bangladesh\">Bangladesh<\/option><option value=\"Belarus\">Belarus<\/option><option value=\"Belgium\">Belgium<\/option><option value=\"Benin\">Benin<\/option><option value=\"Bhutan\">Bhutan<\/option><option value=\"Bolivia\">Bolivia<\/option><option value=\"Bosnia and Herzegovina\">Bosnia and Herzegovina<\/option><option value=\"Botswana\">Botswana<\/option><option value=\"Brazil\">Brazil<\/option><option value=\"Brunei\">Brunei<\/option><option value=\"Bulgaria\">Bulgaria<\/option><option value=\"Burkina Faso\">Burkina Faso<\/option><option value=\"Burundi\">Burundi<\/option><option value=\"Cambodia\">Cambodia<\/option><option value=\"Cameroon\">Cameroon<\/option><option value=\"Canada\">Canada<\/option><option value=\"Central African Republic\">Central African Republic<\/option><option value=\"Chad\">Chad<\/option><option value=\"Chile\">Chile<\/option><option value=\"China\">China<\/option><option value=\"Colombia\">Colombia<\/option><option value=\"Comoros\">Comoros<\/option><option value=\"Costa Rica\">Costa Rica<\/option><option value=\"C\u00f4te d\u2019Ivoire\">C\u00f4te d\u2019Ivoire<\/option><option value=\"Croatia\">Croatia<\/option><option value=\"Cuba\">Cuba<\/option><option value=\"Cyprus\">Cyprus<\/option><option value=\"Czech Republic\">Czech Republic<\/option><option value=\"Denmark\">Denmark<\/option><option value=\"Dominica\">Dominica<\/option><option value=\"Dominican Republic\">Dominican Republic<\/option><option value=\"Ecuador\">Ecuador<\/option><option value=\"Egypt\">Egypt<\/option><option value=\"El Salvador\">El Salvador<\/option><option value=\"Equatorial Guinea\">Equatorial Guinea<\/option><option value=\"Eritrea\">Eritrea<\/option><option value=\"Estonia\">Estonia<\/option><option value=\"Eswatini\">Eswatini<\/option><option value=\"Ethiopia\">Ethiopia<\/option><option value=\"Finland\">Finland<\/option><option value=\"France\">France<\/option><option value=\"Georgia\">Georgia<\/option><option value=\"Germany\">Germany<\/option><option value=\"Ghana\">Ghana<\/option><option value=\"Greece\">Greece<\/option><option value=\"Grenada\">Grenada<\/option><option value=\"Guatemala\">Guatemala<\/option><option value=\"Guinea\">Guinea<\/option><option value=\"Guyana\">Guyana<\/option><option value=\"Haiti\">Haiti<\/option><option value=\"Honduras\">Honduras<\/option><option value=\"Hungary\">Hungary<\/option><option value=\"Iceland\">Iceland<\/option><option value=\"India\">India<\/option><option value=\"Indonesia\">Indonesia<\/option><option value=\"Iran\">Iran<\/option><option value=\"Iraq\">Iraq<\/option><option value=\"Ireland\">Ireland<\/option><option value=\"Israel\">Israel<\/option><option value=\"Italy\">Italy<\/option><option value=\"Jamaica\">Jamaica<\/option><option value=\"Japan\">Japan<\/option><option value=\"Jordan\">Jordan<\/option><option value=\"Kazakhstan\">Kazakhstan<\/option><option value=\"Kenya\">Kenya<\/option><option value=\"Kiribati\">Kiribati<\/option><option value=\"Korea, North\">Korea, North<\/option><option value=\"Korea, South\">Korea, South<\/option><option value=\"Kosovo\">Kosovo<\/option><option value=\"Kuwait\">Kuwait<\/option><option value=\"Kyrgyzstan\">Kyrgyzstan<\/option><option value=\"Laos\">Laos<\/option><option value=\"Latvia\">Latvia<\/option><option value=\"Lebanon\">Lebanon<\/option><option value=\"Lesotho\">Lesotho<\/option><option value=\"Liberia\">Liberia<\/option><option value=\"Libya\">Libya<\/option><option value=\"Liechtenstein\">Liechtenstein<\/option><option value=\"Lithuania\">Lithuania<\/option><option value=\"Luxembourg\">Luxembourg<\/option><option value=\"Madagascar\">Madagascar<\/option><option value=\"Malawi\">Malawi<\/option><option value=\"Malaysia\">Malaysia<\/option><option value=\"Maldives\">Maldives<\/option><option value=\"Mali\">Mali<\/option><option value=\"Malta\">Malta<\/option><option value=\"Mauritania\">Mauritania<\/option><option value=\"Mauritius\">Mauritius<\/option><option value=\"Mexico\">Mexico<\/option><option value=\"Moldova\">Moldova<\/option><option value=\"Monaco\">Monaco<\/option><option value=\"Mongolia\">Mongolia<\/option><option value=\"Montenegro\">Montenegro<\/option><option value=\"Morocco\">Morocco<\/option><option value=\"Mozambique\">Mozambique<\/option><option value=\"Myanmar (Burma)\">Myanmar (Burma)<\/option><option value=\"Namibia\">Namibia<\/option><option value=\"Nauru\">Nauru<\/option><option value=\"Nepal\">Nepal<\/option><option value=\"Netherlands\">Netherlands<\/option><option value=\"New Zealand\">New Zealand<\/option><option value=\"Nicaragua\">Nicaragua<\/option><option value=\"Niger\">Niger<\/option><option value=\"Nigeria\">Nigeria<\/option><option value=\"North Macedonia\">North Macedonia<\/option><option value=\"Norway\">Norway<\/option><option value=\"Oman\">Oman<\/option><option value=\"Pakistan\">Pakistan<\/option><option value=\"Panama\">Panama<\/option><option value=\"Papua New Guinea\">Papua New Guinea<\/option><option value=\"Paraguay\">Paraguay<\/option><option value=\"Peru\">Peru<\/option><option value=\"Philippines\">Philippines<\/option><option value=\"Poland\">Poland<\/option><option value=\"Portugal\">Portugal<\/option><option value=\"Qatar\">Qatar<\/option><option value=\"Romania\">Romania<\/option><option value=\"Russia\">Russia<\/option><option value=\"Rwanda\">Rwanda<\/option><option value=\"Samoa\">Samoa<\/option><option value=\"San Marino\">San Marino<\/option><option value=\"Saudi Arabia\">Saudi Arabia<\/option><option value=\"Senegal\">Senegal<\/option><option value=\"Serbia\">Serbia<\/option><option value=\"Seychelles\">Seychelles<\/option><option value=\"Sierra Leone\">Sierra Leone<\/option><option value=\"Singapore\">Singapore<\/option><option value=\"Slovakia\">Slovakia<\/option><option value=\"Slovenia\">Slovenia<\/option><option value=\"Somalia\">Somalia<\/option><option value=\"South Africa\">South Africa<\/option><option value=\"Spain\">Spain<\/option><option value=\"Sri Lanka\">Sri Lanka<\/option><option value=\"Sudan\">Sudan<\/option><option value=\"Sudan, South\">Sudan, South<\/option><option value=\"Suriname\">Suriname<\/option><option value=\"Sweden\">Sweden<\/option><option value=\"Switzerland\">Switzerland<\/option><option value=\"Syria\">Syria<\/option><option value=\"Taiwan\">Taiwan<\/option><option value=\"Tajikistan\">Tajikistan<\/option><option value=\"Tanzania\">Tanzania<\/option><option value=\"Thailand\">Thailand<\/option><option value=\"The Gambia\">The Gambia<\/option><option value=\"Togo\">Togo<\/option><option value=\"Tonga\">Tonga<\/option><option value=\"Tunisia\">Tunisia<\/option><option value=\"Turkey\">Turkey<\/option><option value=\"Turkmenistan\">Turkmenistan<\/option><option value=\"Uganda\">Uganda<\/option><option value=\"Ukraine\">Ukraine<\/option><option value=\"United Arab Emirates\">United Arab Emirates<\/option><option value=\"United Kingdom\">United Kingdom<\/option><option value=\"United States\">United States<\/option><option value=\"Uruguay\">Uruguay<\/option><option value=\"Uzbekistan\">Uzbekistan<\/option><option value=\"Vatican City\">Vatican City<\/option><option value=\"Venezuela\">Venezuela<\/option><option value=\"Vietnam\">Vietnam<\/option><option value=\"Yemen\">Yemen<\/option><option value=\"Zambia\">Zambia<\/option><option value=\"Zimbabwe\">Zimbabwe<\/option><option value=\"Other\">Other<\/option><\/select><\/span><\/label>\n<\/p>\n<p><label>Template required<br \/>\n<span class=\"wpcf7-form-control-wrap dynamicname\" data-name=\"dynamicname\"><input type=\"text\" name=\"dynamicname\" class=\"wpcf7-form-control wpcf7-text wpcf7dtx wpcf7dtx-text\" aria-invalid=\"false\" required=\"required\" value=\"Management procedure (SOP) Risk management ISO 14971\"><\/span><\/label>\n<\/p>\n<p><label><span class=\"wpcf7-form-control-wrap\" data-name=\"acceptance-privacy\"><span class=\"wpcf7-form-control wpcf7-acceptance\"><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"acceptance-privacy\" value=\"1\" aria-invalid=\"false\" \/><\/span><\/span><\/span> <strong>Privacy. <\/strong> I authorise and consent to the processing of my personal data in accordance with the <a href=\"\/en\/privacy-policy\/#3form\">informative<\/a> provided pursuant to Art. 13 of European Regulation 679\/2016<\/label><br \/>\n<label><span class=\"wpcf7-form-control-wrap\" data-name=\"acceptance-newsletter\"><span class=\"wpcf7-form-control wpcf7-acceptance\"><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"acceptance-newsletter\" value=\"1\" aria-invalid=\"false\" \/><\/span><\/span><\/span> <strong>Subscribe me to the newsletter. <\/strong> I authorise and consent to the processing of my personal data in accordance with <a href=\"\/en\/privacy-policy\/#4newsletter\">informative<\/a> provided pursuant to Art. 13 of the European Regulation 679\/2016<\/label>\n<\/p>\n<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Submit\" \/>\n<\/p><div class=\"fusion-alert alert custom alert-custom fusion-alert-center wpcf7-response-output fusion-alert-capitalize awb-alert-native-link-color\" style=\"--awb-border-top-left-radius:0px;--awb-border-top-right-radius:0px;--awb-border-bottom-left-radius:0px;--awb-border-bottom-right-radius:0px;\" role=\"alert\"><div class=\"fusion-alert-content-wrapper\"><span class=\"fusion-alert-content\"><\/span><\/div><\/div>\n<\/form>\n<\/div>\n<\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_5 1_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:15px;--awb-spacing-right-large:9.6%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:9.6%;--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><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":114,"featured_media":0,"parent":28931,"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-29106","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Management procedure (SOP) Risk management ISO 14971 - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Management procedure (SOP) Risk management ISO 14971 - Thema Med\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema Med\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/\",\"url\":\"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/\",\"name\":\"Management procedure (SOP) Risk management ISO 14971 - Thema Med\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\"},\"datePublished\":\"2023-07-19T08:55:18+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"http:\/\/www.thema-med.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Template\",\"item\":\"https:\/\/www.thema-med.com\/en\/download-template\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Management procedure (SOP) Risk management ISO 14971\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"name\":\"Thema Med\",\"description\":\"Quality and Regulatory Affairs for Medical Devices\",\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.thema-med.com\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":[\"Organization\",\"Place\"],\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\",\"name\":\"Thema\",\"alternateName\":\"Thema\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"width\":2440,\"height\":2851,\"caption\":\"Thema\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/\"],\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Management procedure (SOP) Risk management ISO 14971 - Thema Med","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/","og_locale":"en_US","og_type":"article","og_title":"Management procedure (SOP) Risk management ISO 14971 - Thema Med","og_url":"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/","og_site_name":"Thema Med","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/","url":"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/","name":"Management procedure (SOP) Risk management ISO 14971 - Thema Med","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/#website"},"datePublished":"2023-07-19T08:55:18+00:00","breadcrumb":{"@id":"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"http:\/\/www.thema-med.com\/en\/"},{"@type":"ListItem","position":2,"name":"Template","item":"https:\/\/www.thema-med.com\/en\/download-template\/"},{"@type":"ListItem","position":3,"name":"Management procedure (SOP) Risk management ISO 14971"}]},{"@type":"WebSite","@id":"https:\/\/www.thema-med.com\/en\/#website","url":"https:\/\/www.thema-med.com\/en\/","name":"Thema Med","description":"Quality and Regulatory Affairs for Medical Devices","publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.thema-med.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":["Organization","Place"],"@id":"https:\/\/www.thema-med.com\/en\/#organization","name":"Thema","alternateName":"Thema","url":"https:\/\/www.thema-med.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","width":2440,"height":2851,"caption":"Thema"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/"],"mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/template\/management-procedure-sop-risk-management-iso-14971\/"}}]}},"_links":{"self":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/pages\/29106","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/users\/114"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/comments?post=29106"}],"version-history":[{"count":2,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/pages\/29106\/revisions"}],"predecessor-version":[{"id":29113,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/pages\/29106\/revisions\/29113"}],"up":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/pages\/28931"}],"wp:attachment":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/media?parent=29106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}