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
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.
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...
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. )
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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