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

S

SiriusBlack

#31
#31
MDQSA said:
You can purchase "Comparison Matrix: ISO 13485:2003 and Medical Devices Regulations" from BSI. I think it was about $50 (definitely less than $100) and it compares the 13485 clauses to 21 CFR 820, SOR/98-282 (CMDR), EU MDD & JPAL.
It's a good reference document, but don't take it as gospel. I did find a few omissions, so don't use it in place of the standards.
Click to expand...
Hi -
I've tried searching for this correlation matrix on the BSI site but could not find it. I was hoping perhaps you could send me the link to this publication as this would be exactly what I am looking for!
Thx - Tom
 
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S

sim24kins

#32
#32
Hi SiriusBlack,
I had posted a matrix in a previous posting on this thread (Jan 2010) containing ISO 9001, 13485, CMDR, QSR, MDD and JPAL ~ hope is is what you were looking for :) ~ Cheers
 
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S

SiriusBlack

#33
#33
sim24kins said:
Hi SiriusBlack,
I had posted a matrix in a previous posting on this thread (Jan 2010) containing ISO 9001, 13485, CMDR, QSR, MDD and JPAL ~ hope is is what you were looking for :) ~ Cheers
Click to expand...
Hi -
I cannot seem to find the attachment. Forgive me but I am new to the forum and still learning how to navigate through the tools.

Tom
 
S

sim24kins

#34
#34
Hiya Tom, no problem, just go to Page 3 here to the posting on Jan. 12th (Thread #22) and click on the attachment. Unfortunately, it will not allow me to repost here for convenience.
 
S

SiriusBlack

#35
#35
sim24kins said:
Hiya Tom, no problem, just go to Page 3 here to the posting on Jan. 12th (Thread #22) and click on the attachment. Unfortunately, it will not allow me to repost here for convenience.
Click to expand...
Perfect! Got it and this is EXACTLY what I am looking for! Thank you so very much :)
 
C

clarkes

#36
#36
Thank you to all,
I am currently researching the Regulations in preparation for a job interview and it was wonderful to find so much information in one place.
 
A

apda007

#39
#39
blewispunk said:
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.
Click to expand...
Hi, would you recommend buying this comparision matrix that is available for purchase from BSI website? Also, in which format this comparision is given? Does it quote clause# or also has description of each regulations.
 
L

lenwelshlass

#40
#40
This is really useful and I shall be adopting something similar into my own system.

Does anyone have a really good GMP presentation which I could use to provide internal training. My employer is new in the medical device manufacturing industry so I basically need to start from scratch. It is my role to integrate ISO13485 with ISO9000

Another arm of the business is sachet manufacturing for the cosmetic industry and we are being driven to adopt the principles of ISO 22716 2007 - Guidelines for GMP for Cosmetic Manufacturing.:mg:

I am hoping to be able to pull together a presentation which will cover all aspects of GMP through both of these sections.

As stated in another reply, I dont want to reinvent the wheel!!
Any help would be appreciated.

Many thanks
Helen
 
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