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drewsky1
I am writing a Special 510k and wanted to know from others who may have written one. Is it necessary to include data results of the design verification and validation testing OR is it adequate to include for Des Verification the specification, test methodology/description, and acceptance criteria? And for Des Validation, include the customer specification, acceptance criteria and method. We will, of course, declare conformity to design control procedures as specified in 21 CRF 820.30. I don't think data results is necessary but wanted to make sure before we submit. Any input would be greatly appreciated.
Thanks,
Mijenca
Thanks,
Mijenca