Starrett AV612 (combo vision and touch probe) Galileo Instrument Software Validation

[RoscoeSplevins]

Management and customers are insisting on validation of our Starrett AV612 (combo vision and touch probe). The function is heavily computer program driven, thus we must validate the software, hardware, and data manipulation. I feel confident in setting up the OQ / PQ for the stage and data calculations. BUT how does one go about validating the background software? This is medical related so we must conform the FDA and ISO 13485, and current customer practice.

Thanks in advance.

[Marc]

Can any CMM experts help with this one? My Thanks in advance!