{"id":27729,"date":"2025-11-26T12:51:54","date_gmt":"2025-11-26T12:51:54","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&p=27729"},"modified":"2026-08-27T13:42:32","modified_gmt":"2026-08-27T13:42:32","slug":"iso-13485-unchanged-five-years","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/iso-13485-unchanged-five-years\/","title":{"rendered":"ISO 13485 Remains Unchanged for Another Five Years"},"content":{"rendered":"

Good news for medical device manufacturers: ISO 13485:2016 will remain unchanged for another five years<\/strong>. This means no major changes are to be expected to quality management systems that already comply.<\/p>\n

This was particularly important because the US authority FDA has just updated its own quality management framework<\/strong>. In the new Quality Management System Regulation (QMSR), the FDA references many requirements from ISO 13485:2016<\/strong>. Had ISO 13485 been changed in the meantime, companies would probably have had to make major adjustments to remain compliant in both the USA and the EU.<\/p>\n

The focus now turns to the handbook on ISO 13485<\/strong>, planned as ISO\/TS 23485<\/strong><\/a>. Publication can currently be expected in April 2026 at the earliest<\/strong>.<\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27729","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"\nISO 13485 Remains Unchanged for Another Five Years<\/title>\n<meta name=\"description\" content=\"ISO 13485:2016 remains unchanged for five more years, giving medical device manufacturers stability in quality management requirements.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/quickbirdmedical.com\/en\/news\/iso-13485-unchanged-five-years\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 13485 Remains Unchanged for Another Five Years\" \/>\n<meta property=\"og:description\" content=\"ISO 13485:2016 remains unchanged for five more years, giving medical device manufacturers stability in quality management requirements.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/quickbirdmedical.com\/en\/news\/iso-13485-unchanged-five-years\/\" \/>\n<meta property=\"og:site_name\" content=\"QuickBird Medical\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-27T13:42:32+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/08\/Social-Preview-Fallback-Image.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"3749\" \/>\n\t<meta property=\"og:image:height\" content=\"2109\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\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=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/iso-13485-unchanged-five-years\\\/\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/iso-13485-unchanged-five-years\\\/\",\"name\":\"ISO 13485 Remains Unchanged for Another Five Years\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#website\"},\"datePublished\":\"2025-11-26T12:51:54+00:00\",\"dateModified\":\"2026-08-27T13:42:32+00:00\",\"description\":\"ISO 13485:2016 remains unchanged for five more years, giving medical device manufacturers stability in quality management requirements.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/iso-13485-unchanged-five-years\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/iso-13485-unchanged-five-years\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/news\\\/iso-13485-unchanged-five-years\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/home-neu\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"ISO 13485 Remains Unchanged for Another Five Years\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/\",\"name\":\"QuickBird Medical\",\"description\":\"Entwicklung von medizinischer Software und DiGA\",\"publisher\":{\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#organization\",\"name\":\"QuickBird Medical\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/quickbirdmedical.com\\\/wp-content\\\/uploads\\\/2022\\\/06\\\/QBM_Logo_web-01-1.webp\",\"contentUrl\":\"https:\\\/\\\/quickbirdmedical.com\\\/wp-content\\\/uploads\\\/2022\\\/06\\\/QBM_Logo_web-01-1.webp\",\"width\":875,\"height\":255,\"caption\":\"QuickBird Medical\"},\"image\":{\"@id\":\"https:\\\/\\\/quickbirdmedical.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/de.linkedin.com\\\/showcase\\\/quickbird-medical\\\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"ISO 13485 Remains Unchanged for Another Five Years","description":"ISO 13485:2016 remains unchanged for five more years, giving medical device manufacturers stability in quality management requirements.","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:\/\/quickbirdmedical.com\/en\/news\/iso-13485-unchanged-five-years\/","og_locale":"en_US","og_type":"article","og_title":"ISO 13485 Remains Unchanged for Another Five Years","og_description":"ISO 13485:2016 remains unchanged for five more years, giving medical device manufacturers stability in quality management requirements.","og_url":"https:\/\/quickbirdmedical.com\/en\/news\/iso-13485-unchanged-five-years\/","og_site_name":"QuickBird Medical","article_modified_time":"2026-08-27T13:42:32+00:00","og_image":[{"width":3749,"height":2109,"url":"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/08\/Social-Preview-Fallback-Image.webp","type":"image\/webp"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/quickbirdmedical.com\/en\/news\/iso-13485-unchanged-five-years\/","url":"https:\/\/quickbirdmedical.com\/en\/news\/iso-13485-unchanged-five-years\/","name":"ISO 13485 Remains Unchanged for Another Five Years","isPartOf":{"@id":"https:\/\/quickbirdmedical.com\/en\/#website"},"datePublished":"2025-11-26T12:51:54+00:00","dateModified":"2026-08-27T13:42:32+00:00","description":"ISO 13485:2016 remains unchanged for five more years, giving medical device manufacturers stability in quality management requirements.","breadcrumb":{"@id":"https:\/\/quickbirdmedical.com\/en\/news\/iso-13485-unchanged-five-years\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/quickbirdmedical.com\/en\/news\/iso-13485-unchanged-five-years\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/quickbirdmedical.com\/en\/news\/iso-13485-unchanged-five-years\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/quickbirdmedical.com\/en\/home-neu\/"},{"@type":"ListItem","position":2,"name":"ISO 13485 Remains Unchanged for Another Five Years"}]},{"@type":"WebSite","@id":"https:\/\/quickbirdmedical.com\/en\/#website","url":"https:\/\/quickbirdmedical.com\/en\/","name":"QuickBird Medical","description":"Entwicklung von medizinischer Software und DiGA","publisher":{"@id":"https:\/\/quickbirdmedical.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/quickbirdmedical.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/quickbirdmedical.com\/en\/#organization","name":"QuickBird Medical","url":"https:\/\/quickbirdmedical.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/quickbirdmedical.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2022\/06\/QBM_Logo_web-01-1.webp","contentUrl":"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2022\/06\/QBM_Logo_web-01-1.webp","width":875,"height":255,"caption":"QuickBird Medical"},"image":{"@id":"https:\/\/quickbirdmedical.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/de.linkedin.com\/showcase\/quickbird-medical\/"]}]}},"_links":{"self":[{"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/news\/27729","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/news"}],"about":[{"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/types\/news"}],"wp:attachment":[{"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/media?parent=27729"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/categories?post=27729"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/tags?post=27729"},{"taxonomy":"display","embeddable":true,"href":"https:\/\/quickbirdmedical.com\/en\/wp-json\/wp\/v2\/display?post=27729"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}