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




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


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.


Fully vaccinated are you?
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


I am looking for the same spreadsheet. Anyone created or found a good one?
Inquiring minds would love to know!


Involved In Discussions
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
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?


Involved In Discussions
No - I'm not with that company. I would expect that if it were proprietary that it would be noted o the document itself.
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