Lets say its a PEMS, like a pulse oximeter.

The QMS (13485) is pending approval.

The device has passed NRTL safety testing, and the same NRTL also approved its risk management file, 62304, and 14971 documents.

We have yet to actually write any real (formal) work instructions for production line testing.

We aren't sure what actually determines what testing is needed.

My guess: the QMS specifies the design specifications and performance of the device, and so processes in the QMS (work instructions) which are intended to be used to create that device need to have their outputs verified and/or validated, which then creates the tests needed.

But this brings up an esoteric question: what links the work instructions themselves to the NRTL approved device? The device top-level functional requirements, essential performance, ...?


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I do a Process FMEA to determine what in-process and final acceptance tests are suitable.

The BOM + DMR (FDA) / whatever you use to satisfy 7.5.1(a) in 13485 + design transfer provides the linkage. You should be able to show equivalence using those items to what was tested by the lab.