{"id":640909,"date":"2024-11-06T01:19:01","date_gmt":"2024-11-06T01:19:01","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-tr-80002-22017\/"},"modified":"2024-11-06T01:19:01","modified_gmt":"2024-11-06T01:19:01","slug":"iso-tr-80002-22017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-tr-80002-22017\/","title":{"rendered":"ISO\/TR 80002-2:2017"},"content":{"rendered":"

ISO\/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.<\/p>\n

ISO\/TR 80002-2:2017 applies to<\/p>\n

– software used in the quality management system,<\/p>\n

– software used in production and service provision, and<\/p>\n

– software used for the monitoring and measurement of requirements.<\/p>\n

It does not apply to<\/p>\n

– software used as a component, part or accessory of a medical device, or<\/p>\n

– software that is itself a medical device.<\/p>\n","protected":false},"excerpt":{"rendered":"

Medical device software \u2014 Part 2: Validation of software for medical device quality systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ISO<\/b><\/a><\/td>\n2017-06<\/td>\n92<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":640921,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,704,2634],"product_tag":[],"class_list":{"0":"post-640909","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","7":"product_cat-35-240-80","8":"product_cat-iso","10":"first","11":"instock","12":"sold-individually","13":"shipping-taxable","14":"purchasable","15":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/640909","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\/640921"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=640909"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=640909"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=640909"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}