Diane,
I've written CERs, which have been well accepted by NBs.
The CERs should be written in a methodically sound procedure showing "collection, appraisal and analyses of clinical data to a subject device demonstrating clinical evidence SUFFICIENT to confirm compliance with the applicable essential requirements for the device safety and performance.
The CERs should fully address MEDDEV 2. 7.1 (REV 4) issued on June 2016.
Upon demand, I can put together a training seminar on the topic with my recent experience.
Thank you.
s/ David
______________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA
REGULATORY DOCTOR
Phone (Toll-Free): 1-(800) 321-8567
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