Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

Ronen E

Problem Solver
Moderator
The DMR is not required to include any “documents generated to demonstrate conformity” with anything (though one might get away with excess, I grant). The DMR contents may demonstrate conformity but they are mostly generated for another purpose - prescribing the realisation of the device as intended.

Furthermore, I never said anywhere that the medical device file needs to be “a whole separate file”. It is required to reference documents where it doesn’t include them. For all I know the medical device “file” can be a single page, covered with references. Either way, just having a bunch of compliant production Work Instructions that each reference ISO 13485:2016 may be generally in compliance with the standard but it won’t fulfil (in my opinion) the requirements of 4.2.3.
 
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E

EthanLoh

MDSAP audit is based on ISO 13485 requirements + national regulatory requirements (e.g. USA, Canada, Brazil, Australia and Japan).

If you do ISO 13485 upgrade and follow by MDSAP. Your certification bodies will love to have you as a client. You just pay double audit fees. I am sure you can bargain for a discount. :lol:
 
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