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Old 13th January 2017, 04:24 PM

Total Posts: 202
Re: EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday

The normative section of both versions of the standards are identical.
The only difference is that EN ISO 13485:2016 contains informative Z annexes that describe the relationship between the Standard and the MDD, and it basically states that the Standard does not provide presumption of conformity with all aspects of whatever the Annex you use for claiming compliance.

Some national standards bodies issue their own version of the standards or the annexes by themselves that you can get for lower price or even free if you search around (not for commercial use though).
Thank You to mihzago for your informative Post and/or Attachment!

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