{"id":640526,"date":"2024-11-06T01:17:00","date_gmt":"2024-11-06T01:17:00","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-tr-249712020\/"},"modified":"2024-11-06T01:17:00","modified_gmt":"2024-11-06T01:17:00","slug":"iso-tr-249712020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-tr-249712020\/","title":{"rendered":"ISO\/TR 24971:2020"},"content":{"rendered":"<p>This document provides guidance on the development, implementation and maintenance of a <i>risk management<\/i> system for <i>medical devices<\/i> according to ISO 14971:2019.<\/p>\n<p>The <i>risk management<\/i> <i>process<\/i> can be part of a quality management system, for example one that is based on ISO 13485:2016<sup>[<\/sup><sup>24<\/sup><sup>]<\/sup>, but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to <i>risk management<\/i> and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: <i>ISO<\/i> <i>13485<\/i><i>:<\/i><i>2016<\/i> \u2014<i> Medical devices <\/i>\u2014<i> A practical guide<\/i><sup>[<\/sup><sup>25<\/sup><sup>]<\/sup>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Medical devices \u2014 Guidance on the application of ISO 14971<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/iso\/\"><b>ISO<\/b><\/a><\/td>\n<td>2020-06<\/td>\n<td>94<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":640540,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2634],"product_tag":[],"class_list":{"0":"post-640526","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-iso","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/640526","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/640540"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=640526"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=640526"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=640526"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}