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Hi there,
I'm just looking for a regulation that governs tracebility for medical devices. Specifically my question is: Is it ok to use 2 lots of a component in a sub-assembly Lot History Record. In other words mix componentsbut record both lots numbers. This would mean should you need to trace the materials, you would need to investigate both components. Is this prohibited/ok and if so what is the regulation. I know I have seen this done in Med device LHRs in the past.
thanks,
Elmer
I'm just looking for a regulation that governs tracebility for medical devices. Specifically my question is: Is it ok to use 2 lots of a component in a sub-assembly Lot History Record. In other words mix componentsbut record both lots numbers. This would mean should you need to trace the materials, you would need to investigate both components. Is this prohibited/ok and if so what is the regulation. I know I have seen this done in Med device LHRs in the past.
thanks,
Elmer