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How does ISO 9000 compare with the FDAs Medical Device Quality System Regulation?

April 26, 2017compare device fda ISO medical quality regulation system

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How does ISO 9000 compare with the FDAs Medical Device Quality System Regulation?

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FDA’s Medical Device Quality System Regulation includes elements from ISO 9000 as well as other international standards. The Medical Device Quality System Regulation is mandatory as stated by the FDA, while ISO 9001 is a voluntary quality management system. Click here for more information on training programs for FDA-regulated industries.