In Reply to Parent Post by Marc
Can you be more specific?
Just pitching in, while DannyK would write back ...
By your 13485 QMS if you are to respect
FDA requirement (your medical devices may be getting into USA) or
MDD / IVD requirements (your medical devices may be getting into EU) or
CMDR requirements (your medical devices may be geting into Canada) or
the respective regions regulatory requirements wherever your medical devices will be entering the market
These requirements becomes a part of your QMS activities, and they get to be mentioned in your QMS documentation, and addressed accordingly. These will be audited by you in internal audits and by the CB or NB etc etc.