In Reply to Parent Post by MIREGMGR
Normally risk management is the responsibility of the Manufacturer, not the contract manufacturer/contract designer.
Perhaps your contract with the Manufacturer calls for you to perform this analysis for them. That's fine, but it doesn't change who is responsible for the work, and it doesn't change the fundamental need for the risk analysis to be done as if by the Manufacturer, taking into account the product's "life cycle phases" from their perspective...not yours.
I definitely agree with what is written above BUT.....
1) I am putting a ISO 14971 RM program in place to placate auditors who jump on me for not having a RM program during ISO 13485 audits. (I know, I know....not a good reason to implement RM.)
2) My customers don't have the manufacturing expertise so my company doing the RM from a manufacturing point makes more sense.
I have no choice on implementing an ISO 14971 RM system.
That is also my frustration with ISO 13485 and ISO 14971. They are both writtten from the perspective that you are The Manufacturer. I would love to see explicit callouts for subcontractor activities.