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Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
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Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations
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  Post Number #1  
Old 25th July 2006, 12:50 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,656
Thank You! Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations

I would like to create a chart comparing the CMDR and MDD to FDA regulations. I looked through the post attachments list and unless I missed it, there isn't one. Does someone already have something similar that they can post? Thanks

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  Post Number #2  
Old 26th July 2006, 07:22 AM
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Kevin Mader

 
 
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Re: Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations

Al,

I seem to recall one here as I think I have a print out of it somewhere. I'll take a look. It is possible I got it from somewhere else, but I'll look.

Kev
  Post Number #3  
Old 26th July 2006, 09:16 AM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,656
Re: Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulati

Quote:
In Reply to Parent Post by Kevin Mader

Al,

I seem to recall one here as I think I have a print out of it somewhere. I'll take a look. It is possible I got it from somewhere else, but I'll look.

Kev
I thought there was one too, but I couldn't find it. I found one called Regulatory Requirements that compared the CMDR to the MDD and Australian regulations, but I think it was incomplete in comparing them to the FDA requirements.
  Post Number #4  
Old 27th July 2006, 10:09 PM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,656
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations

Maybe I can give this a bump. I'm still looking for a good comparison table for these regs.
  Post Number #5  
Old 28th July 2006, 07:40 AM
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wrodnigg

 
 
Total Posts: 254
Re: Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulati

There is a comparison table for 9001, 13485 and QSR from Ed Kimmelman, which can be downloaded here. It is from Quality-Works.com

I have reviewed this table and did some corrections and added some comments to the 13485/MDD section (I also sent them to Ed, maybe he already included them in his version of the table).

The upload of the file failed, but I can provide it by email...

Last edited by Marc; 28th July 2006 at 08:00 AM. Reason: Changed deep link from external site and gave credit to Quality-Works
Thanks to wrodnigg for your informative Post and/or Attachment!
  Post Number #6  
Old 28th July 2006, 07:48 AM
Al Rosen's Avatar
Al Rosen

 
 
Total Posts: 3,656
Re: Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulati

Thanks, I have that and was hoping to add the CMDR to it.
  Post Number #7  
Old 10th August 2006, 03:05 PM
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Steve McQuality

 
 
Total Posts: 108
Re: Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations

Al:

Did you ever find what you were looking for regarding the comparison? I found an old post in the Cove, but I'm assuming you were aware of this one since you were involved in the thread - but it was 2+ years ago. Here's the link:
ISO 13485, FDA's QSR, CMDR, MDD: Seeking Correlation Matrix

Look as the attachment to Post #8. Is this what you were looking for?

-Steve
(OOPS!! Just looked back at the post you said you already found - and I found the same one. Sorry 'bout that. )
  Post Number #8  
Old 8th December 2006, 04:08 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,205
Re: Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulati

Quote:
In Reply to Parent Post by Al Rosen View Post

Thanks, I have that and was hoping to add the CMDR to it.
Al, did you get it ?
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