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Victoria7
I am new to medical device and the company I work for doesn't have a Design Control Procedure. Everything I read says we need it. The CEO says we buy finished 510k's and put them in a convenience kit using the customer specs therefore we are not designing anything. The company has an ISO 9001:2008 certification with thier QSM saying they are exempt because of the reasons mentioned above.I found a LOT of info in FDA Guidance for Design Control, Medical Device QSM Compliance guide, 21CFR 820 and ISO 9001:2008. Looking for clarity.
Confused
Confused