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Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820
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Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820
Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820
Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820
Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820
Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820
Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820
Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820
Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820
Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820
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Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820 - Page 2


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21 cfr part 820 - med. device mfger. qsr requirements, checklist or check sheet, iso 13485:2016
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  Post Number #9  
Old 12th October 2017, 07:06 PM
Ronen E

 
 
Total Posts: 3,512
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

Quote:
In Reply to Parent Post by mrstekstar View Post

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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  Post Number #10  
Old 12th October 2017, 07:32 PM
funkgirl's Avatar
funkgirl

 
 
Total Posts: 17
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

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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  Post Number #11  
Old 12th October 2017, 08:21 PM
Ronen E

 
 
Total Posts: 3,512
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

Quote:
In Reply to Parent Post by funkgirl View Post

No - I'm not with that company. I would expect that if it were proprietary that it would be noted o the document itself.
My question was addressed to mrstekstar, who uploaded the document.
BTW, copyright applies even at the absence of an explicit claim. The name Oriel STAT A MATRIX appears on the single page uploaded, however.
  Post Number #12  
Old 13th October 2017, 09:30 AM
Edward Reesor

 
 
Total Posts: 39
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

Perhaps a reminder that broadcasting private or proprietary information is what got this forum in hot water not too long ago.

For everyone else out there, please, please, please do not send attachments from your company or whats available online unless you have permission. If you want to make up something yourself and post it, that's another story.
  Post Number #13  
Old 13th October 2017, 01:23 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,560
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

The attached MDSAP Companion Document from the IMDRF has the information you are looking for. BTW, it's not copyrighted.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf MDSAP G0002.1004 Companion Document_rev 2017-04-13.pdf (1.09 MB, 9 views)
Thanks to Al Rosen for your informative Post and/or Attachment!
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