Dr Training Records - Training doctors to use a PMA approved medical device

#1
Does anyone know what requirements exist for training doctors to use a PMA approved medical device? Do I need to maintain training records for each Dr who will be using our device?
 
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Ronen E

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#2
I would think that if such training appeared in the PMA submissions it would constitute part of the approval, and would be obliging. Keeping records would be required to be able to demonstrate following through.
 

pziemlewicz

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#3
I agree with the above on submission.

Additionally, the answer to this question can come out of your risk assessment / risk management process. If class / device risk is low, likely the user guide will suffice. The higher it gets, the more you up your management of training and competency. It sometimes helps to think of this in the context of how you deliver, install, and service the device.
 
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