Changing supplier of critical raw material (III class device)

#1
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?
 
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#2
Marilyn,

presuming you have an established quality system, assess the impact of this change in terms of whether the V&V activities you performed on your device with existing supplier would be affected by this supply change. Your "normal" change control procedure should cover all aspects relevant for your device, including how to qualify new suppliers. Since you already had qualified the existing raw-material supplier successfully at some point in time, you would have an internal precedence of how to qualify an equivalent new supplier.

HTH,
 
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