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The folks from Emergo Group have a very nice outline of how to think and approach FDA inspection readiness, before the FDA actually shows up at your door.
"In order to meet US Food and Drug Administration (FDA) requirements, medical device manufacturers active in the US market must undergo FDA audits of their quality management systems to demonstrate compliance with Quality System Regulation 21 CFR Part 820, also known as Good Manufacturing Practice (GMP)."'via Blog this'
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