Hi,
We are manufacturing III class custom-made medical devices (no CE certificate). What quality activities are required if I change the supplier of critical raw material? The specification of the raw material stays the same as it is already accepted. So the raw material itself will not change.
I´m wondering, if I should perform the evaluation of this new supplier just according our normal procedure of "supplier evaluation"? Or is there something more I have to consider?
We are manufacturing III class custom-made medical devices (no CE certificate). What quality activities are required if I change the supplier of critical raw material? The specification of the raw material stays the same as it is already accepted. So the raw material itself will not change.
I´m wondering, if I should perform the evaluation of this new supplier just according our normal procedure of "supplier evaluation"? Or is there something more I have to consider?
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