MDR Canada vs. MDR USA

M

mbomba99

#1
hello all, looking through our PMA, as we prepare for a third party audit, For ISO 13485 and cmdcas. Realized we need to have procedures in place for medical device reporting for canada,(europe if we do CE). Can any one give me a general web site were I can find this info.
 
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Cordon - 2007

#2
Scroll down to the bottom of this page and click on one the older threads; they might be just what your looking for. :cfingers:
 

Al Rosen

Staff member
Super Moderator
#3
hello all, looking through our PMA, as we prepare for a third party audit, For ISO 13485 and cmdcas. Realized we need to have procedures in place for medical device reporting for canada,(europe if we do CE). Can any one give me a general web site were I can find this info.
I think youu can use this to start. It's part of another procedure that covers complaints and mdrs for the world. I extracted the section for Canada.
 

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