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?
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?