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Major differences between 21 CFR Part 820 and ISO 13485?

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fda (food and drug administration), iso 13485 - medical device qms, 21 cfr part 820 - med. device mfger. qsr requirements
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  #1  
Old 17th November 2008, 04:03 PM
abchris

 
 
Posts: 3
Please Help! Major differences between 21 CFR Part 820 and ISO 13485?

We currently have a quality system based on CFR part 820. What we would have to add to be complaint with ISO 13485?

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  #2  
Old 17th November 2008, 06:09 PM
GStough's Avatar
GStough

 
 
Posts: 1,105
Re: Major differences between part 820 and iso 13485?

Quote:
In Reply to Parent Post by abchris View Post

We currently have a quality system based on CFR part 820. What we would have to add to be complaint with ISO 13485?

Hello abchris, and welcome to the Cove!

Here is a thread that may answer your question, and a file attachment that you may find useful in determining the differences between 21 CFR Part 820 and ISO 13485:2003.

Comparison of 21 CFR 820 and ISO 13485

If this doesn't adequately meet your needs, there are other discussions in the ISO 13485 - Medical Devices forum (scroll to the bottom of this page and click on the drop-down menu for the forums) that may have more of what you're looking for.

I hope this helps.
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  #3  
Old 17th November 2008, 08:08 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Posts: 5,709
Re: Major differences between part 820 and iso 13485?

In addition to Gidget advise, I can direct you to another informative post by a fellow moderator, Al Rosen where you will find a matrix between ISO 13485 and 21 CFR Part 820 - Al's post in Differences: ISO 13485 vs. FDA QSR (820)

You could also have a look at the parent thread Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets for more info.
Thanks to Ajit Basrur for your informative Post and/or Attachment!
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