Is Validation of Plating Processes required and who is responsible?

[outdoorsNW]

If the customer does not specify, it is worth asking if the job is a prototype where it is too soon to validate the process.

I worked on a medical electronics project years ago where the early prototypes were to prove the concept worked and I was specifically told to notify the designer but otherwise ignore certain quality issues until either the 3rd or 4th prototype generation. There were enough design changes happening that validating something likely to have significant changes before the design was finalized was a waste of time.

 

[duinyk]

I have a related question.

Is process validation required before filling a 510k or can batch testing work for that, in this case it will be an aseptic filling process. Is it possible to file a 510k without a process validation in place?

Thanks