Re: Identifying gaps over ISO 13485 to be compliant to EEC 93/42/EEC requirements
Hi,
In terms of QMS, there's nothing in the MDD that is not covered by ISO 13485. ISO 13485 compliance provides presumption of conformity with all MDD QMS requirements.
On the other hand, there are many requirements in MDD that are not covered by ISO 13485, becuase they are not QMS-specific. I'm not aware of a matrix showing that, but then I don't really rely on templates when implementing the MDD. I believe that the best way is to read the MDD itself on each and every implementation. I don't believe in canned thinking, though I understand why folks like it.
Cheers,
Ronen.