ISO 13485 vs the Canadian MDR SOR/98-292

P

PattySQE

#1
Hello,

I'm hoping to get some help. Does there exist a chart or some type of guide that compares and contrasts ISO 13485 and the Canadian MDR? I understand that they are quite similar but there are some differences. Does any one know where I can find this delta?

Thanks
 
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DannyK

Trusted Information Resource
#2
Hello,

I'm hoping to get some help. Does there exist a chart or some type of guide that compares and contrasts ISO 13485 and the Canadian MDR? I understand that they are quite similar but there are some differences. Does any one know where I can find this delta?

Thanks
Refer to GD210. You can google it and it provides a list of requirements that must be reviewed by the auditor.
 
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