{"id":27542,"date":"2021-12-22T07:48:17","date_gmt":"2021-12-22T06:48:17","guid":{"rendered":"https:\/\/www.testify.io\/glossar\/iso-13485\/"},"modified":"2026-09-09T19:37:44","modified_gmt":"2026-09-09T17:37:44","slug":"iso-13485","status":"publish","type":"glossary","link":"https:\/\/www.testify.io\/en\/glossar\/iso-13485\/","title":{"rendered":"ISO 13485"},"content":{"rendered":"<nav aria-label=\"breadcrumbs\" class=\"rank-math-breadcrumb\"><p><span class=\"last\">Startseite<\/span><\/p><\/nav>\n<h1><strong>What does ISO 13485 contain?<\/strong><\/h1>\n<p><strong>ISO 13485<\/strong> is an international standard that represents the requirements for an effective quality management system for the design and manufacture of medical devices. It is relevant for all companies in the supply chain and for placing products on the market that are regulated by the relevant EU regulations. For the approval of medical devices, their safety and functionality must be proven as part of the conformity assessment procedures required in Europe.  <\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Related links:<\/strong><\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"U3ZckG4EIi\"><p><a href=\"https:\/\/www.testify.io\/en\/solutions\/quality-control\/\">Qualit\u00e4tskontrolle<\/a><\/p><\/blockquote>\n<p><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201cQualit\u00e4tskontrolle\u201d \u2014 Testify\" src=\"https:\/\/www.testify.io\/en\/solutions\/quality-control\/embed\/#?secret=9pZHta05r3#?secret=U3ZckG4EIi\" data-secret=\"U3ZckG4EIi\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/p>\n","protected":false},"excerpt":{"rendered":"<p>What does ISO 13485 contain? ISO 13485 is an international standard that represents the requirements for an effective quality management system for the design and manufacture of medical devices. It is relevant for all companies in the supply chain and for placing products on the market that are regulated by the relevant EU regulations. For [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"template":"","class_list":["post-27542","glossary","type-glossary","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.testify.io\/en\/wp-json\/wp\/v2\/glossary\/27542","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.testify.io\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/www.testify.io\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/www.testify.io\/en\/wp-json\/wp\/v2\/users\/4"}],"wp:attachment":[{"href":"https:\/\/www.testify.io\/en\/wp-json\/wp\/v2\/media?parent=27542"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}