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The FDA has decided to replace its current system with ISO 13485, the organization has announced. The purpose is to help streamline regulatory processes for medical devices across the world.
Published in 2016, ISO 13485 is the international standard for quality management systems for the medical device sector. The regulation is designed to work efficiently and transparently with other management systems across the world.
Expect a first quarter release of ISO 13485 for medical device manufacturers. Voting on the Final Discussion version of ISO 13485 concluded December 29, 2015 and now the wait is on for the 2016 revision to be officially released.
ISO 13485 was last revised in 2003. The latest update of ISO 13485 is to the 2008 version of ISO 9001 NOT the 2015 version. Structurally, the updated ISO 13485 uses 8 sections rather than the 10 sections found in ISO 9001:2015.
Read more: Revised Medical Device Standard...
ASR is continuing its practice of sharing with clients the most frequent sections of the following standards found to be nonconforming by ASR auditors.
