Correlation matrix of ISO 13485 and other country regulations

M

Matoux

#1
Hi,
in order to ensure my company have included all relevant requirements into the QMS and to prepare for external audits I've been asked to develop a correlation matrix between ISO 13485:2012 and other country specific regulations (e.g. CMDCAS, PMDL, AMGRD, ANVISA etc). I am finding this much more difficult to complete than I expected. Has anyone else worked on something similar and may have some pointers for me?

Many thanks
:confused:
 
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M

Matoux

#3
Hi Mihzago,

thank you for replying. Unfortunately I've been unable to find anything in the post attachments so far. Those I have found compare ISO 13485 and 9001, but I'm more interested in country specific differences.
Matoux
 

somashekar

Staff member
Super Moderator
#4
The 5th attachment in THIS search list, gives you the 13485 + FDA 21 CFR 820 effectively covered. This pretty much also covers the ANVISA RDC 16 requirements within per my assessment. So your work is half done.
Again welcome to the COVE
 
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