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ISO 13485, FDA's QSR, CMDR, MDD: Seeking Correlation Matrix

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calimar75

#21
#21
Hi All,
Can anyone confirm whether the compliance matrix noted in one of the previous posts contains the current revision of the MDD? I have called BSI and no one can confirm so I was hoping that perhaps someone in the forum who has purchased it recently could confirm if contains the current MDD revision.

Thanks.
-David
 
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S

sim24kins

#22
#22
ISO 9001, ISO 13485, ISO 14001, FDA's QSR, CMDR, MDD & PAL Correlation Matrix

Hi Fellow Regulatory / Quality Professionals,

Here is the Regulatory Correlation Matrix I've prepared relating ISO 9001, ISO 13485, ISO 14001, 21 CFR Part 820 QMS, MDD 93/43/EEC (as amended by Directive 2007/47/EC) and Japan's PAL (MHLW Ordinance 169). Although I cannot guarantee it's accuracy, our Notified Body was extremely pleased with the matrix, any feedback or verification of accuracy is welcome. Hope this is helpful!
 

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B

blewispunk

#23
#23
I have a comparison matrix that I purchased from BSI a few years back. Unfortunately it doesn't have a document number on it anywhere but I'm sure you could find it on their site. It compares ISO 13485, FDA QSR, Canadian CMDR, the MDD, and JPAL.
 
C

CBAL08

#24
#24
Re: ISO 9001, ISO 13485, ISO 14001, FDA's QSR, CMDR, MDD & PAL Correlation Matrix

sim24kins said:
Hi Fellow Regulatory / Quality Professionals,

Here is the Regulatory Correlation Matrix I've prepared relating ISO 9001, ISO 13485, ISO 14001, 21 CFR Part 820 QMS, MDD 93/43/EEC (as amended by Directive 2007/47/EC) and Japan's PAL (MHLW Ordinance 169). Although I cannot guarantee it's accuracy, our Notified Body was extremely pleased with the matrix, any feedback or verification of accuracy is welcome. Hope this is helpful!
Click to expand...
Just want to confirm if the MDD is the latest one???:thanx:
 
Q

qamama

#25
#25
Compliance...Not sure if you'll receive this as this is old, but the typr of document you are talking about is exactly what I need. Especially with reference to MDD/CMDR. If you still have may I see?
 
C

calimar75

#26
#26
Hi All,
FYI: I received the BSI document today. It was revised 08-31-09 and states in the introduction that it was updated to include the latest changes to the MDD.
 
Q

qamama

#27
#27
Re: 13485, CMDR, FDA, MDD, & Japan

Thanks QA-MAN for this. This is exactly what I was after :) I can't thank you enough......
 
Q

qamama

#28
#28
Calimar75: Would it be appropriate to say that if you looked at QA-MANs document, that nothing has changed? I would think that the numbering system would be the same, but the content different and when auditing the standard verbiage not the number is what matters :)
 
C

calimar75

#29
#29
QAMAMA/All:
The lists provided in this thread are great resources but shouldn't be considered gospel. The standards are all open to some form of interpretation because of how open ended they are written. This is evidenced in the differences wehn comparing the two lists provided earlier in this thread or when comparing the correlation matrix from BSI with the GD210. With that said I am trying to use all of these resources to put together my own matrix which includes 210/211 as well, since my company makes combination products.
 
S

SiriusBlack

#30
#30
Dan LaBelle said:
Hello hello,
Working for a Medical Device company that designs, manufactures, and distributes devices throughout the world, there are 4 key standards requirements that need to be compliant to as of today anyways. As an auditor, I must ensure that my organization is compliant to them and make sure that I am covering all applicable elements of each standard during each audit that I conduct.

My question is: does anyone know of or have an example of a Matrix that compares ISO 13485: 1996/2003, FDA QSR requirements, Canadian Medical Device Requirements (CMDR), and the Medical Device Directives (MDD) in one document. It would be a helpful tool and also proof to our external auditors that our internal audit system is covering all applicable requirements during internal audits.

I have attached my current matrix that doesn't include CMDR and MDD. I have been working on adding both these requirements but am having difficulties because of the semantic nature of how these requirements have been written. Another words, CMDR written by Canadians. MDD written by the European Union and they both have their own way of writing things in a long novel style.

Thanks, Look forward to hearing from you all.
Click to expand...
Hi - I am trying to pull together the same correlation matrix. Were you able to find what you were looking for? If so, I too could use a bit of help :)

Tom
 
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