Registering Medical Products in Canada - DIN EN 14971 vs. CAN/CSA-ISO 14971

[AbsoluteBeginner]

Hello everybody

I have a question: we want to register our Medical Products in Canada and therefore i read its necessary to implement the requirements of the CAN/CSA-ISO 14971. I wonder where the differences are regarding the risk management. Does anyone know something about it?
:truce:

Thanks a lot in advance!!!

 

[DannyK]

There is no difference. Make sure you use the latest version of ISO 14971.

 

[AbsoluteBeginner]

perfect! Thanks for the very fast reply!!
so i can just refere to EN 14971? and do i have to buy the Canadian 14971. Just to show that we follow their requirements? Or am i fine with the EN 14971?

 

[Ronen E]

perfect! Thanks for the very fast reply!!
so i can just refere to EN 14971? and do i have to buy the Canadian 14971. Just to show that we follow their requirements? Or am i fine with the EN 14971?

I reckon if you don't purchase a legal copy of the Canadian version (~280 Euro for the PDF version), you'd have to document how you verified that there is no difference. I'm not sure how well will an auditor accept a post on a web forum (no offence to poster)...

 

[DannyK]

I am a CMDCAS lead assessor and if you follow ISO 14971:2007, you will not have any problems with any CMDCAS auditor.

 

[Rocke]

There is no difference. Make sure you use the latest version of ISO 14971.

Just a minor technicality., but actually, you do not want to quote the most recent DIN version, which is :2009.
It is the 2007-version that is harmonized in Canada. So if quoting the 2009-version, you should maybee include a statement that 2007 and 2009 are identical except for additional informative annexes in the 2009 version.