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What Is "FDA 21 CFR Part 820" Compliant eQMS Software?
Anonymous
about 2 years ago
We are a startup and are in the early stages of getting our medical device FDA approved. We are currently looking at eQMS software to manage our QMS process. We have to adhere to the “FDA 21 CFR Part
Accepted
1 answer
There’s no such thing as “21 CFR Part 820” compliance or certification. Only the content matters - i.e., the documents you create. You could create th