To Whom it may concern:
My company recently had an ISO 13485 audit in one of its facilities. We are a custom manufacturing company that does not design or make its own product. We manufacture cables, wiring and harnesses. My question is, can an ISO 13485 auditor cite FDA 820 nonconformances when my company is not FDA registered and we do not make any medical devices?
Regards,
C-Ana
My company recently had an ISO 13485 audit in one of its facilities. We are a custom manufacturing company that does not design or make its own product. We manufacture cables, wiring and harnesses. My question is, can an ISO 13485 auditor cite FDA 820 nonconformances when my company is not FDA registered and we do not make any medical devices?
Regards,
C-Ana