I agree with all of the posts above, however I would like to elaborate on the high level understanding of verification and validation testing, based off my experience at Stryker. I was able to see many of these “tests” done on the patient specific cut guides created for ankle replacement surgeries. The verification of the device included many tests to confirm the 3D printed pieces were manufactured accurately within the tolerances planned in ProE. Basically, to verify that the part was created properly to maintain high standards. The validation of the cut guides consisted heavily of surgeon feedback to confirm the goals of the device has been met. For example, feedback about the fit of the cut guides in the cadaver labs, the ease of use, and time saved during the procedure were all ranked on a numeric scale. There was no outlined procedure for all of the V&V tests needed to be done, however the engineers on my team had to follow similar tests done for other medical devices to make the process smoother.