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See today's BioWorld MedTech
Home » Consultant: Notion that ISO 13485 and Part 820 are 95% harmonized is not supported
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The Food and Drug Law Institute Annual Conference

Consultant: Notion that ISO 13485 and Part 820 are 95% harmonized is not supported

Oct. 9, 2020
By Mark McCarty
Several senior managers at the Center for Devices and Radiological Health (CDRH) have been pushing the convergence between U.S. FDA and international quality systems standards, often with the claim that the two standards already are nearly completely aligned. However, Jack Garvey, CEO of Compliance Architects LLC, ran through a side-by-side comparison of ISO 13485 and Part 820 and maintained that the two standards are too conceptually and textually different to plausibly assert that they are 95% harmonized.
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