{"id":27777,"date":"2024-08-09T09:24:30","date_gmt":"2024-08-09T09:24:30","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&p=27777"},"modified":"2026-09-03T13:56:15","modified_gmt":"2026-09-03T13:56:15","slug":"fda-harmonises-rules-iso-13485","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/fda-harmonises-rules-iso-13485\/","title":{"rendered":"FDA Harmonises Existing Rules With ISO 13485"},"content":{"rendered":"

In December 2023<\/strong>, the FDA is carrying out an update<\/strong> of 21 CFR 820 (Quality System Regulation) to align it with the specifications of ISO 13485:2016.<\/p>\n

The aim of this revision is to promote more advanced risk management principles<\/strong> while at the same time reducing the regulatory burden<\/strong> for manufacturers and importers of medical devices by harmonising national and international requirements.<\/p>\n

This development is positive above all for medical device manufacturers from the EU that have already established a quality management system in accordance with ISO 13485<\/strong>.<\/p>\n

The FDA provides information on the alignment here:<\/p>\n

https:\/\/www.reginfo.gov\/public\/do\/eAgendaViewRule?pubId=202210&RIN=0910-AH99<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27777","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"\nFDA Harmonises Existing Rules With ISO 13485<\/title>\n<meta name=\"description\" content=\"FDA updates 21 CFR 820 to align Quality System Regulations with ISO 13485:2016, streamlining compliance for device makers.\" \/>\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\/fda-harmonises-rules-iso-13485\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Harmonises Existing Rules With ISO 13485\" \/>\n<meta property=\"og:description\" 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