The verification and validation process can be very lengthy, especially because of all of the detail that is required. I wouldn’t necessarily say that there are risks within the V&V process itself, but potentially because of the amount of time it takes. For example, if a test failed, or if the engineers cannot figure out how to perform the specific test, and validate that method of testing, it can add on additional months to the project timeline. Pushing back the project because of delays can ultimately be risky as the medical device industry is very competitive, and ideally the device will hit the market as fast as possible.