The difference between verification and validation is well explained by considering the question that each is trying to answer. Verification answers the question, “Did we make the device right?” while validation answers the question, “Did we make the right device?” Both are very important in the process of device development. The challenges that can come during verification can include parts that are out of spec. When this happens, there is usually an investigation to try and figure out why the part was not made according to the way it was said it was supposed to be made, which will cause delays to the project. Validation can be more challenging because you need to prove that you made the right device. This is done by providing evidence that the device meets all of the market requirement specifications. The risk with this is that if you cannot provide justification for why your product works the way that it should, then you will have to return back to the early stages of development and reconsider the device.