Dear
I searched through the cove under 13485 , Still I have not found the required process of developing Risk managenment as Sub contractor ,
AT present we are contract manufacturer of medical device . We do not make finished devices, and do not market/brand any finished products. Our customer is "encouraging" us to pursue registration to 13485 because they are registered to 13485. and going for FDA audit
The risk management to finished product level is maintained by Our customer .
I request help from Cove users to guide me in writting procedure / share the risk management procedure .that can be used for contract manufacturer of medical device
regards
Gprasadhc