Hello all.
As a contract manufacturer of an "implantable finished medical devices" that are returned in bulk to the client for sterilization, final packaging, labeling, distribution, sale, etc., to what extent to we have to implement ISO 13485:2016 Section 7.5.9.2? Is the client the only "distributor" that we have have traceability requirements for, or do we need to require it for all of THEIR distributors, as well?
Additionally, regarding FDA 21 CFR 821, is there a way to predict if the FDA will issue an order for serialization?
Thanks much.
As a contract manufacturer of an "implantable finished medical devices" that are returned in bulk to the client for sterilization, final packaging, labeling, distribution, sale, etc., to what extent to we have to implement ISO 13485:2016 Section 7.5.9.2? Is the client the only "distributor" that we have have traceability requirements for, or do we need to require it for all of THEIR distributors, as well?
Additionally, regarding FDA 21 CFR 821, is there a way to predict if the FDA will issue an order for serialization?
Thanks much.