The verification and validation reports provide evidence for a company that their product inputs will directly lead to the product output. In order to confirm this is true you must design a test to validate the claims. These tests that Dr. Simon mentioned are going to differ according to different projects. As our classmates have discovered through their research, the FDA does not have any regulation to how these tests are conducted. The FDA leaves you a guideline as to what these tests must accomplish. If these tests do not accomplish these guidelines they will not suffice. Therefore the design verification tests must ensure that all design outputs meet the design input requirements. The design verification will include identification of the design, methods, the date, and individuals performing the verification. This information will be documented in the Design History File.