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Hello!
We are a contract manufacturer with no design responsibility. We, however have a group that develops processes & works collaboratively with our customers who are both the Spec developers & Medical Device mfgs. The question - if we want to include this group under our 13485 registration, what would be required? Is it simply to ensure that our Quality Planning process adequately covers what they do or do we have to comply with the full-blown 7.3 D & D section? Thanks!!
We are a contract manufacturer with no design responsibility. We, however have a group that develops processes & works collaboratively with our customers who are both the Spec developers & Medical Device mfgs. The question - if we want to include this group under our 13485 registration, what would be required? Is it simply to ensure that our Quality Planning process adequately covers what they do or do we have to comply with the full-blown 7.3 D & D section? Thanks!!