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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


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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 #1  
Old 23rd July 2016, 06:22 PM
statman78

 
 
Total Posts: 34
Please Help! Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

Hi,

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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  Post Number #2  
Old 24th July 2016, 10:19 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,030
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

With some history: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets

Major differences between 21 CFR Part 820 and ISO 13485

Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

And: ISO 13485 vs. 21 CFR Part 820: How To Distinguish Between Standard Conformity And Regulatory Compliance
Thank You to Marc for your informative Post and/or Attachment!
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  Post Number #3  
Old 24th July 2016, 10:29 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,030
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

Oh, and see the discussions here: http://Elsmar.com/Forums/search.php?...uery=13485+820 and some of the files here: http://elsmar.com/Forums/fileslist.p...criteria=13485
Thank You to Marc for your informative Post and/or Attachment!
  Post Number #4  
Old 24th July 2016, 11:28 AM
statman78

 
 
Total Posts: 34
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

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.
  Post Number #5  
Old 24th July 2016, 05:33 PM
Marc's Avatar
Marc

 
 
Total Posts: 26,030
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

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.
  Post Number #6  
Old 1st September 2016, 03:59 PM
connieb's Avatar
connieb

 
 
Total Posts: 1
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

curious if you have found one yet. I am in need of one also and don't want to reinvent the wheel
  Post Number #7  
Old 1st December 2016, 03:45 PM
jcongress

 
 
Total Posts: 1
Re: Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820

I am looking for the same spreadsheet. Anyone created or found a good one?
Inquiring minds would love to know!
  Post Number #8  
Old 1st December 2016, 05:44 PM
funkgirl's Avatar
funkgirl

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

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...
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