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we had a legacy product that finished design five years ago, and we got 510K two years ago.
Recently we were noticed that FDA will audit our site this April.
Now I have a concern for design control, do we need to finish design verification and validation activities etc like new NPI?
Or we need not care about this legacy product, we just need to make sure the DMR available?
Recently we were noticed that FDA will audit our site this April.
Now I have a concern for design control, do we need to finish design verification and validation activities etc like new NPI?
Or we need not care about this legacy product, we just need to make sure the DMR available?