ISO 13485 vs the Canadian MDR SOR/98-292

[PattySQE]

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

 

[DannyK]

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.

 

[PattySQE]

Thanks for the quick response.

 

[TWA - not the airline]

Search the "Medical Device Related Regulations" Forum, Subforum "Canada Medical Device Regulations" right here in the Cove.


Best,

TWa