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

Al Rosen

Staff member
Super Moderator
#1
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
 

Kevin Mader

One of THE Original Covers!
Admin
#2
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
 

Al Rosen

Staff member
Super Moderator
#3
Re: Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulati

Kevin Mader said:
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.
 

wrodnigg

Inactive Registered Visitor
#5
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 a moderator:

Al Rosen

Staff member
Super Moderator
#6
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.
 

Steve McQuality

Quality Engineer
#7
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.:bonk: :eek: )
 
M

Madly RA'd Woman

#9
Re: Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulati

Hi Al:

If you found one, I need a copy too. We got cited on not having one in our last audit, so anything you can provide would be greatly appreciated.

Thanks!
Madly RA'd!:cfingers: :bigwave:
 
F

freelovefest

#10
Re: Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulati

Has anyone managed to rwangle this document out yet? I have attempted and done poorly. I need to develop a compliance matrix in relation to audit findings and am having trouble getting the CMDR added.

Any progress anyone has made on creating this document would be much appreciated. Thanks for all the great info and posts.
 

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