EN ISO 14971:2012 - Implementing Annex Z content deviations

RobertvanBoxtel

Involved In Discussions
#1
By now, all have had a chance to assess the Annex Z-s that are included in the EN ISO 14971:2012, harmonized without transition period on August 30, 2012.
I am new to this forum and have tried to find actual practical approaches that manufacturers can take to meet these requirements. And I could not find a discussion on this.
Therefore, this new Thread:
How did you implement the requirements of the Annex ZA, ZB and/or ZC in your QMS, more specifically your RM SOP's, forms, plans and reports, without creating a separate RM file for the EU only?

Based on the feedback, I would like to share some challenges I encountered when implementing it with together with my clients.
 
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sagai

Quite Involved in Discussions
#2
I think if you and your Notified Body takes the most effort intensive resolution for the deviations, than the applied rigour will be the superset of the complexity defined in ISO14971:2007.
Cheers!
 
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