{"id":7429,"date":"2018-07-03T16:06:22","date_gmt":"2018-07-03T14:06:22","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7429"},"modified":"2023-01-24T14:59:32","modified_gmt":"2023-01-24T13:59:32","slug":"usa-medical-device-qms-soon-harmonized","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/","title":{"rendered":"USA: Medical device QMS soon harmonized"},"content":{"rendered":"<p><img decoding=\"async\" class=\"alignleft size-full wp-image-7425\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg\" alt=\"\" width=\"281\" height=\"180\" \/><\/p>\n<p>The FDA has declared its intention to harmonize and modernize <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=820\" target=\"_blank\" rel=\"noopener\">21CFR 820<\/a>, the regulation of the Quality Management System (QMS) related to medical devices.<\/p>\n<p>&nbsp;<\/p>\n<p>The existing Quality System requirements will be replaced with the specifications of the harmonized International Standard <strong>EN<\/strong>\u00a0<strong>ISO 13485:2016<\/strong>.<\/p>\n<p>This revision aims to reduce compliance and documentation retention obligations for device manufacturers by harmonizing national and international requirements.<\/p>\n<p>Indeed, these changes will align 21CFR 820 with the harmonized ISO 13485: 2016 Standard.<\/p>\n<p>In April 2019 the FDA will publish a first proposal under public consultation through a Notice of Proposed Rulemaking (<a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/RulesRegulations\/default.htm\" target=\"_blank\" rel=\"noopener\">NPRM<\/a>).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has declared its intention to harmonize and modernize 21CFR 820, the regulation of the Quality Management System (QMS) related  [&#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":[679,2],"tags":[],"class_list":["post-7429","post","type-post","status-publish","format-standard","hentry","category-blog-en","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USA: Medical device QMS soon harmonized - 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\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"USA: Medical device QMS soon harmonized - Thema Med\" \/>\n<meta property=\"og:description\" content=\"The FDA has declared its intention to harmonize and modernize 21CFR 820, the regulation of the Quality Management System (QMS) related [...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema Med\" \/>\n<meta property=\"article:published_time\" content=\"2018-07-03T14:06:22+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-24T13:59:32+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg\" \/>\n<meta name=\"author\" content=\"redazione\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"redazione\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/\"},\"author\":{\"name\":\"redazione\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\"},\"headline\":\"USA: Medical device QMS soon harmonized\",\"datePublished\":\"2018-07-03T14:06:22+00:00\",\"dateModified\":\"2023-01-24T13:59:32+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/\"},\"wordCount\":97,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg\",\"articleSection\":[\"BLOG\",\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/\",\"url\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/\",\"name\":\"USA: Medical device QMS soon harmonized - Thema Med\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg\",\"datePublished\":\"2018-07-03T14:06:22+00:00\",\"dateModified\":\"2023-01-24T13:59:32+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#primaryimage\",\"url\":\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg\",\"contentUrl\":\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.thema-med.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"USA: Medical device QMS soon harmonized\"}]},{\"@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\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\",\"name\":\"redazione\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"caption\":\"redazione\"},\"sameAs\":[\"http:\/\/www.thema-med.eu\"],\"url\":\"https:\/\/www.thema-med.com\/en\/author\/emanuele\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"USA: Medical device QMS soon harmonized - 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\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/","og_locale":"en_US","og_type":"article","og_title":"USA: Medical device QMS soon harmonized - Thema Med","og_description":"The FDA has declared its intention to harmonize and modernize 21CFR 820, the regulation of the Quality Management System (QMS) related [...]","og_url":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/","og_site_name":"Thema Med","article_published_time":"2018-07-03T14:06:22+00:00","article_modified_time":"2023-01-24T13:59:32+00:00","og_image":[{"url":"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg","type":"","width":"","height":""}],"author":"redazione","twitter_card":"summary_large_image","twitter_misc":{"Written by":"redazione"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#article","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/"},"author":{"name":"redazione","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e"},"headline":"USA: Medical device QMS soon harmonized","datePublished":"2018-07-03T14:06:22+00:00","dateModified":"2023-01-24T13:59:32+00:00","mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/"},"wordCount":97,"publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#primaryimage"},"thumbnailUrl":"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg","articleSection":["BLOG","News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/","url":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/","name":"USA: Medical device QMS soon harmonized - Thema Med","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#primaryimage"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#primaryimage"},"thumbnailUrl":"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg","datePublished":"2018-07-03T14:06:22+00:00","dateModified":"2023-01-24T13:59:32+00:00","breadcrumb":{"@id":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#primaryimage","url":"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg","contentUrl":"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/FDA.jpg"},{"@type":"BreadcrumbList","@id":"https:\/\/www.thema-med.com\/en\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.thema-med.com\/en\/"},{"@type":"ListItem","position":2,"name":"USA: Medical device QMS soon harmonized"}]},{"@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\/2018\/07\/03\/usa-medical-device-qms-soon-harmonized\/"}},{"@type":"Person","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e","name":"redazione","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","caption":"redazione"},"sameAs":["http:\/\/www.thema-med.eu"],"url":"https:\/\/www.thema-med.com\/en\/author\/emanuele\/"}]}},"_links":{"self":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/7429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/comments?post=7429"}],"version-history":[{"count":1,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/7429\/revisions"}],"predecessor-version":[{"id":26827,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/7429\/revisions\/26827"}],"wp:attachment":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/media?parent=7429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/categories?post=7429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/tags?post=7429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}