Do you have separate clinical risk management group or experts in your manufactures?

#1
As per the requirement of EU MDR, it seems it should have a separate clinical risk management group or experts for medical device manufactures.
Is this idea correct?
in the past, R&D responsible for the whole risk management, but they only focus on the device design related hazards and situation.
As I am a clinical evaluator, I think its quite necessary to invite medical affairs or product manager with clinical background to list and analyze all the hazards may occurred.
however, the difficulty is, it seems can not find someone or a training focus on clinical risk management, telling out how to set up the criteria, how to set up the acceptable level, although I can refer to 14971/ 24971.
would you please provide some suggestions?
 
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shimonv

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#2
From my experience, clinical risks are kept together with the design risks, and the risk management team includes a clinical expert, whether employee or consultant.

Shimon
 

Al_Z1

Starting to get Involved
#3
We added to RM group medical physicist with several years of clinical experience with the device with equivalent clinical effect and intended use.
 

Junn1992

Quite Involved in Discussions
#4
Any good relationships with your doctor clients? I'm sure they will be happy to stand in as clinical evaluator or consultant for you
 
#5
Any good relationships with your doctor clients? I'm sure they will be happy to stand in as clinical evaluator or consultant for you
yes, I agree that the doctors will support as consultant, but their information may still limited, because they do not know how to do risk analysis, product life cycle evaluation and the requirements of regulations.
 
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