Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820


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I am looking ISO 13485 2016 & CFR Part 820 Checklist that provides a direct comparison between the new standard and part 820. I know there are several that exist for the older standard, but wanted to see if something has been developed for the new standard. Thank you
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Thanks Marc. Your links were helpful, but the links and attachments refer to the 2003 standard. I am looking for the more recently released 2016 standard comparison with the QSR. A clause by clause comparison with part 820.


Hunkered Down for the Duration
Staff member
Hopefully someone will have one to share. I Googled a bit and found one, but it was a "give us your email address and we'll send you one. I tried it before I put in a link to the site here, but an hour later and still no email, so I won't put the link in.

If you find one, please let us know.


curious if you have found one yet. I am in need of one also and don't want to reinvent the wheel


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I'm looking too, but would ideally like something that includes 13485: 2016 and all of the MDSAP countries. Will post if I find something...

Ronen E

Problem Solver
Staff member
I am attaching a sample page of an MDSAP audit matrix that I have found helpful. It lists ISO 13485:2016, 21CFR820 and MDSAP countries. The entire file is 25 pages long, so I cannot attach it in its entirety. If you think this would be helpful to you, let me know, I would be happy to email it to you.
It seems to belong to Oriel Stat a Matrix. Is it proprietary? Are you associated with this company?
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