We recently had an ISO 13485 audit and was issued a non-conformance for not having a DMR. Do you need to have a DMR if you are only producing a component consisting of only one item?
Any help would be appreciated.
Terminology aside, I assume that when you agreed with your NB that they would certify your QMS to ISO 13485, you provided them with some information on at least one medical device that you make, so that they and you could agree on a scope statement to go in the certificate. Is the product that you're describing that medical device?
If in fact you aren't currently producing any medical devices, and the product you're describing is in your view just a component for someone else's medical device, does the NB agree?
It sounds to me as if they think the product that you're describing as a component is in fact a medical device within the certificate scope. I'd think that issue would need to be sorted out between the NB and you.