Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

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?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#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

Involved In Discussions
#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.
 
Top Bottom