Verification & Validation requirements - Patch that adheres to skin

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
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?
 

yodon

Leader
Super Moderator
One way or another, I think you'll have to address it. Will extending the shelf life have any impact on the adhesive? (Presuming you say 'no,' what's the rationale?)
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Perhaps I wasn't clear. We are considering shelf life extension a risk to the adhesive life. We plan on doing testing involved in adhesive with real human subjects ass part of validation. Do we also have to verify the force requirements as well? One could say we don't know the safety factor with only validation.
 
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