{"id":15167,"date":"2020-08-05T15:29:16","date_gmt":"2020-08-05T13:29:16","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15167"},"modified":"2022-07-27T06:51:06","modified_gmt":"2022-07-27T04:51:06","slug":"eu-iso-14971-application-guide-has-been-published","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/08\/05\/eu-iso-14971-application-guide-has-been-published\/","title":{"rendered":"EUROPE: the ISO 14971 application guide has been published"},"content":{"rendered":"\r\n<p>The second edition of the <strong>application guide ISO 14971<\/strong> \u201cMedical devices &#8211; Application of risk management to medical services\u201d was published last June 2020. It is a worldwide-accepted ISO standard for the application of <strong>risk management to medical devices<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p>This second edition invalidates and replaces the first edition.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-15153\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/08\/eu-guida-applicazione-iso-14971-1-1024x536.png\" alt=\"The ISO 14971 application guide has been published\" \/>\r\n<figcaption>The ISO 14971 application guide has been published<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>What are the main changes from the previous edition?<\/strong><\/h2>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>The clauses of ISO\/TR 24971:2013 and some informative annexes of ISO 14971:2007 have been restructured, technically revised and supplemented with additional guidance.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>To facilitate the use of this guide, the same structure and numbering of clauses and sub-clauses is used as in ISO 14971:2019. In addition, there are informative annexes containing further guidance on specific aspects of risk management.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>ISO 14971: who is this guide for?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>The ISO 14971 application guide <strong>assists Manufacturers<\/strong> in developing, implementing and maintaining a risk management process for medical devices, which aims to <strong>meet ISO 14971:2019 requirements<\/strong>. The application concerns a wide variety of medical devices, such as implantable and non-implantable devices, active and non-active devices, software as a medical device and IVDs.<\/p>\r\n\r\n\r\n\r\n<p>In addition, this risk management process is part of the <strong>ISO 13485:2016 Quality Management System<\/strong>. There are, in fact, some requirements of ISO 13485:2016 that are related to risk management and can be met by applying ISO 14971.<\/p>\r\n\r\n\r\n\r\n<p>To evaluate the applicability of this document&#8217;s guidance, it is important to consider the nature of the medical devices to which it will apply, by whom and how these devices will be used, and what the applicable regulatory requirements are.<\/p>\r\n\r\n\r\n\r\n<p class=\"has-medium-font-size\"><strong>Need more information? Trust our Thema consultants!<\/strong><\/p>\r\n\r\n\r\n\r\n<p>Our Thema consultants can provide you with the right support through <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">strategic-regulatory consulting<\/a>.<\/p>\r\n\r\n\r\n\r\n<p><strong><a href=\"https:\/\/www.thema-med.com\/en\/certification-iso-13485-the-best-for-medical-devices-and-ivd\/\">ISO 13485<\/a><\/strong><a href=\"https:\/\/www.thema-med.com\/en\/certification-iso-13485-the-best-for-medical-devices-and-ivd\/\">: <\/a><strong>find out why it is the best certification for medical devices and in vitro diagnostic medical devices!<\/strong><\/p>\r\n\r\n\r\n\r\n<p><strong><a href=\"mailto:sales@thema-group.it\">CONTACT US<\/a><\/strong> for more information!<\/p>\r\n\r\n\r\n\r\n<p>And if you would like to stay updated on Thema activities, subscribe to our <strong><a href=\"https:\/\/www.thema-med.com\/en\/newsletter\/\">newsletter<\/a><\/strong>!<\/p>\r\n\r\n\r\n\r\n<p><em>Sources:<\/em> <br \/><br \/><a href=\"https:\/\/bit.ly\/30h5JI6\">https:\/\/bit.ly\/30h5JI6<\/a><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/bit.ly\/2BKDzvC\">https:\/\/bit.ly\/2BKDzvC<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>The second edition of the application guide ISO 14971 \u201cMedical devices &#8211; Application of risk management to medical services\u201d was published  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-15167","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EUROPE: the ISO 14971 application guide has been published<\/title>\n<meta name=\"description\" content=\"The second edition of the ISO 14971 application guide has been published. It is an ISO standard for the application of risk management ...\" \/>\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\/2020\/08\/05\/eu-iso-14971-application-guide-has-been-published\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EUROPE: the ISO 14971 application guide has been published\" \/>\n<meta property=\"og:description\" content=\"The second edition of the ISO 14971 application guide has been published. 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