i see a lot of you have gave their opinion on the matter of how to trying to get the best strategy to take when the validation and verification had fail. Now we know is really bad when this two fail, so we have to make sure before everything is done properly to “never” counter this matter, so we have to consider that instead of rushing to design verification, the opposite approach might be more beneficial. spend more time defining design inputs and that design verification becomes smoother, leaving 0 change to fail. implementing this approach will help who ever is working on this medical device to have a better design input and help you to have the ability to manage medical device product development.