Question

Evidence that requirements in R-TF-012-037 Labeling and IFU Requirements have been verified and/or validated could not be found. For example, a plan for verification/validation of requirements in labeling and IFU requirements, traceability demonstrating that the requirements been verified and/or validated, associated test protocols and results, and summary information in a verification or validation report could not be found. Please provide the location of this information or provide updated documentation if necessary.