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ISO 13485:2016 (finally) published

25 February 2016, Geneva: ISO published the long-awaited ISO 13485:2016 yesterday. It's available for purchase at click here for 158 CHF (approx 158 US$). It's not yet available on any of the standards websites (AAMI, ANSI, NSAI, etc.) but soon will be. There's no...

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Testing to 60601-1-2 for your next 510(k)/PMA?

The FDA has issued “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”Draft Guidance on On November 2, 2015,. Based on the guidance, 510(k)/PMA submitters are to submit 9 specific deliverables one of which is the corresponding IEC 60601-1-2:2007 (3rd edition) test reports supporting EMC claims.

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