Hi Vintage Goose -thank you for your reply Just querying - Is ISO13485:2016 7.3.6 not more applicalbe to Statistical Methods for Determining...
thanks for reply Sorry Bev D, I don't understand what you mean ?
Hiya Atul, Havent a clue what the poll options Prompt was supposed to be for I just couldn't submit the post , without entering something for it.
Hi Yodon , thanks for reply Capability Studies , i mean eg; Process Performance asessment as part of validation periodic review. medical devices...
HI Guys, Are Capability Studies a regulatory requirement ? I am referring to the Medical Device Industry Appreciate some advice and guidance...
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