MDSAP and 13485:2016 gap analysis

MDRexpert

Involved In Discussions
Can someone please share gap analysis done for ISO 13485:2016 and MDSAP for Canada and U.S?

Thanks!
 

Jen

Starting to get Involved
Maybe you can try starting with attached MDSAP Companion Document? It has clearly outlined the difference between ISO13484 with Canada and the US.
 

Attachments

  • MDSAP G0002.1.004 Companion Document.pdf
    1.2 MB · Views: 359
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