Design verification means confirming by objective evidence (i.e. testing) that the design outputs meet design inputs. Design Verification is one of the most important activities in the development phase of a medical device. It is a rigid rule as there are predecessor and successor activities that happen prior and after design verification. For example, in order for design verification to occur the design needs to be finalized (“freeze”) and equipment in place to manufacture it. Only then the medical device can be manufactured and tested. Design Validation ensures the design meets user needs and intended use. Just as Design Verification it is a critical activity and can only happen after the design has passed design verification. There is a process to the design controls that works to minimize design flaws which ultimately benefits the end user and the company.