We have a single medical device that is a patch that adheres to skin and reports temperature. We are extending the shelf life on real time aged patches. We have a Design Input of a force (lbs) requirement to keep the patch adhered to skin for up to 72 hours. We also have a validation report that had users actually apply the patches for 72 hours to validate that requirement works at the user experience level.
To extend the shelf life, aside from the functional electrical requirements of function, must we test both the DI force requirement AND the validation method again? Can we just perform the validation?
To extend the shelf life, aside from the functional electrical requirements of function, must we test both the DI force requirement AND the validation method again? Can we just perform the validation?