Medical equipment company supplier
Yes, as a supplier of medical device manufacturers, the requirement is to meet the traceability of medical devices. As long as the materials (such as circuit boards) produced by the manufacturers according to the requirements of medical device manufacturers can be used as suppliers of medical device manufacturers, ISO 13485 is not mandatory. Moreover, not all medical device manufacturers have passed ISO 13485. How can suppliers be forced to provide them, as long as they meet the traceability requirements?