I manage production and service for a medical component and device manufuacturer. Part of my role is complaints handling through our service department.
I undestand the 13485 and FDA QSR requirements for complaints for our medical devices, but not our medical components. If a medical component is sent back to us from our OEM customer (who manufactures a medical device), does this constitute a complaint? For example - the OEM customer sends back a component we shipped them, which failed their incoming inspection.