IQ of test equipment used ONLY during Design Verification?

Forbes82

Registered
Hello,

We are developing a new, complex IVD device. As you'd hope, we are completing process validation (IQ and ideally OQ) for production processes prior to Design Verification. However, there are some pieces of equipment which play no part in device manufacture or routine inspection but they are used solely for testing during Design Verification e.g. an automated force testing machine (with software etc). The force testing machine has calibration and maintenance in hand, and we will complete TMV/Test Method Validation (gage R&R) on each test method.

I've worked places before which insisted an IQ was completed before TMV and Design Verification. But I'm on the fence about it, as it's for a one-off use effectively. Does anyone have any thoughts? Process validation definitions seem to limit the scope to production and supporting inspections processes.

Thanks
 

yodon

Leader
Super Moderator
Is it important to do IQ to ensure that the TMV results can be considered reliable?

I don't expect those that insist on it could cite chapter and verse where the requirement is (I don't think it exists - unless it's in an internal document) but I can see rationale for doing so.
 
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