Hi Everyone, Hope you're all doing well! I have some quality experience from Pharma and some lab work both QA and QC. I have just started a new...
Hello! I am looking for some input on the idea of a "catch up" 510k. When you have made several minor changes that only required a letter to...
Hi Everyone, Just curious: has anyone (successfully) attempted to push-back against an FDA observation that items in one of their guidance...
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