S
Shaka256
Hi again, not sure what's the best way for conformity assessment in case of OEM and PLM:
Company A: designs and produces many medical devices
Company B: asks company A to make small changes to some of the products and label it under company B name (it is identified as the manufacturer).
Now company B wants to get a CE certificate under the MDR- is the only way to do it is type examination + production quality assurance?
Or can company B apply according to annex IX even though it doesn't have a QMS for design and production?
Company A: designs and produces many medical devices
Company B: asks company A to make small changes to some of the products and label it under company B name (it is identified as the manufacturer).
Now company B wants to get a CE certificate under the MDR- is the only way to do it is type examination + production quality assurance?
Or can company B apply according to annex IX even though it doesn't have a QMS for design and production?