From a regulatory standpoint, is a medical device manufacturer required to verify every dimension/specification on a drawing as part of first article inspection for a new part? Can the manufacturer take a risk based approach if it is not feasible to verify every dimension? The alternative would be to verify every critical to quality specification and to rely on the supplier's FAI results for the remaining verifications.
For the aerospace industry AS9102 requires that anything noted on the drawing be verified, however I am uncertain if a similar requirement exists for the medical device industry.
-Laurie
Hello and welcome to the cove
I'm not aware of a similar requirement to verify everything on the drawing, in a medical device regulation or international standard.
Risk-based approach is common with medical devices, and if you have reasonable justifications documented (and readily accessible) you should be all right in most cases.
I'm not 100% sure I understand what stage you refer to by "as part of first article inspection for a new part", though. Do you refer to the beginning of every batch / lot production run, or to the first lot ever produced? If you refer to the first case, then I would say yes, it makes a lot of sense to verify critical requirements and handle all the rest with less rigour (it is up to you to decide how - e.g. rely on your supplier FAI - and document your justifications); If the latter then I would recommend everything is verified and documented at least once as part of a proper design and development process.
Please also note that requirements validated as part of process validation do not formally require verification on a regular basis, though you might like to monitor the process performance at some level, as a safety measure.
Cheers,
Ronen.
