![]() The QSRs define minimum criteria for a medical device company regarding design, manufacturing, packaging, labeling, storage, installation, and servicing of medical devices sold and distributed in the United States Let me explain why.įirst, what is ISO 13485:2016? And what is FDA 21 CFR Part 820?įDA 21 CFR Part 820 is the quality system regulations that the United States has been following since 1996. ![]() Earlier this year, the FDA announced their intentions to change the US’s current medical device regulations from FDA 21 CFR Part 820 to ISO 13485:2016.
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