Risk Analysis on Medical Device Instructions for Use?

Ajit Basrur

Staff member
Admin
#11
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
Prasad, use the search function available at the top of the screen or see the related threads below. There are some good attachments and info on Risk Analysis for Medical Products.
 
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gprasadhc

#12
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
 

Ajit Basrur

Staff member
Admin
#13
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