Where a medical device company develops the specifications for a device product that is to be manufactured by a contract manufacturer what are the spec developer requirements under ISO 13485? Anyone have any experience with what 13485 provisions must typically me met?
Hi,
I've helped some specification developers build and run their ISO 13485 compliant QMS. The guiding principle is that you need to apply all the sections that pertain to what you
actually do. This can mean the majority of the sections, i.e. everything but those that directly relate to production. Perhaps create an applicability matrix where you list all the standard requirements by clauses, indicate applicable/NA, and provide a rationale wherever you put "NA" in.
Please feel free to PM me if you're looking for someone to walk you through. Otherwise, good luck!
Cheers,
Ronen.