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ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison
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ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison
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  Post Number #1  
Old 7th October 2016, 09:04 AM
al40's Avatar
al40

 
 
Total Posts: 508
Please Help! ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison

Trying to understand differences between ISO 13485:2003 and ISO 13485:2016

Thanks,
Al40

Last edited by al40; 7th October 2016 at 09:18 AM.

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  Post Number #2  
Old 7th October 2016, 09:21 AM
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Marc

 
 
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Re: ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison

You might want to start here: ISO 13485:2016 Gap Analysis
Thank You to Marc for your informative Post and/or Attachment!
  Post Number #3  
Old 7th October 2016, 08:40 PM
Ronen E

 
 
Total Posts: 3,736
Re: ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison

There's a free white paper about it from BSI.
There's one from Emergo as well.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #4  
Old 27th January 2017, 04:22 PM
caseym

 
 
Total Posts: 6
Question Re: ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison

Hello, hello
It is not clear to me if anyone has already done a line by line comparison of 13485:2003 vs 13485:2016, which highlights the changes from each section. Similar to Tracked Changes (or Software Code Review tools). I did this for section 7 for my company but now they want the entire document reviewed and I am almost certain someone has done that. If there is a cost with this then let me know that also.
-later
  Post Number #5  
Old 18th April 2018, 11:00 AM
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solutions

 
 
Total Posts: 12
Re: ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison

You can purchase a redline .pdf version of 13485:2016 which shows all additions and deletions.

ISO 13485:2016 - Medical devices -- Quality management systems -- Requirements for regulatory purposes
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