Virtual Manufacturer and Risk Management

#1
Hi All

I just wanted to get peoples opinion on risk management requirements from OEMs as the virtual manufacturer.

I'm in a situation where we're the virtual manufacturer. I've reviewed the risk management work from the OEM and its well below the standard that we would perform on our own products.

Would you expect the OEM to match your standard of work or just to conform to ISO14971?

Thanks
Will.
 
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pkost

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#2
Whoever is the legal manufacturer is responsible, whether they are a virtual manufacturer or not. If you (as legal manufacturer) do not believe the quality is sufficient it is your responsibility to fix (however that may be).

Ultimately it is the legal manufacturers neck on the block if something goes wrong.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Would you expect the OEM to match your standard of work or just to conform to ISO14971?
This question suggests that your standard of work significantly exceeds ISO 14971. From a regulatory perspective, that's probably an overkill. I can't think of a regulatory system that I know that would not suffice with "just" ISO 14971 conformance (that's normally not a small thing).
 
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