To tag onto the original post - I work for an initial importer / distributor of Med Devices in the US as the QA/RA rep. We do supply our own artwork to the suppliers for private labeling. I have been keeping up with Design History of our artwork, revision control, etc.
One question I do have regarding regulatory as a distributor (in the past, I have worked at the manufacturer or med devices) - when evaluating / selecting suppliers for products, how far into the details should I go? For instance, I do check to ensure they have a
510K for the specific products, but for sterile products, I will usually ask to see their dose settings / does audits or sterilization validations. For expiration dates, I will ask to see stability studies to confirm it can hold up to FDA scrutiny. Is this too much? Should I just be ensuring that the facility is registered, the product is registered and the 510K exists (for applicable products requiring 510Ks)?