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Comparison between ISO13485 and 93/42/EEC Medical Device Directive


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  Post Number #1  
Old 27th December 2007, 01:48 PM
C Logan

 
 
Total Posts: 8
Please Help! Comparison between ISO13485 and 93/42/EEC Medical Device Directive

I am looking for a comparison guide like the GD210, which compares ISO13485:2003 to SOR/98 - 282, only comparing ISO 13485:2003 to the 93/42/EEC Medical Device Directive.

Anyone have clues if there is something comparable out there? I need to do a GAP analysis between our current QMS and what would require tweaking for the EEC standard.

Any help would be greatly appreciated.

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  Post Number #2  
Old 27th December 2007, 03:49 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
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Re: Comparison between ISO13485 and 93/42/EEC Medical Device Directive

There´s no direct comparison between ISO 13485 and the Medical Devices Directive because they´re different things. ISO 13485 is a standard for the implantantion of a quality system for medical devices manufacturers. The MDD is a legislation which adresses essential principles for the safety and performance of medical devices during their lifecycle. One os the requirements of the MDD is a requirement for a quality system or some similar control, so you can use ISO 13485 to fulfill some of these requirements.

If you want a document that relates the essentials principles (which are the Annex I of the MDD and also from the GHTF) to the standards you could use to fulfill them, i strongly recomment "ISO/TR 16142:2006 - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices"

Last edited by Marcelo Antunes; 27th December 2007 at 04:29 PM.
Thank You to Marcelo Antunes for your informative Post and/or Attachment!
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  Post Number #3  
Old 27th December 2007, 03:54 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,046
Re: Comparison between ISO13485 and 93/42/EEC Medical Device Directive

Quote:
In Reply to Parent Post by mmantunes View Post

If you want a document that relates the essentials principles (which are the Annex I of the MDD and also from the GHTF) to the standards you could use to fulfill them, i strongly recomment "ISO/TR 16142:2006 - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices"
mmantunes,

Thank you for the reference. Here is the link to the ISO catalogue.

Stijloor.
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