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Medical component manufacturer and complaint handling

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Created:   Feb 02, 2023 Last commented:   Feb 06, 2023

Medical component manufacturer and complaint handling

Hello.

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. 

Thank you! 

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Kristina Zvonar Brkić Feb 06, 2023

Yes, of course, it is a complaint. You need to do an inspection of what went wrong with that component, and why it is not accepted by the OEM because obviously, something went wrong within your production process. 

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Feb 02, 2023

Feb 06, 2023