ABSTRACT
Design change control Why do we need to control changes during design and development? Aren’t we still trying to figure it all out?
Design change control is just one more way to ensure quality. Anyone who has ever been involved with the development of a medical device is aware that many changes occur between the original concept and the device that is ultimately transferred to production and released for distribution. If we remember that design control is a cyclical process, then it is important to know where we’ve been and how and why we got to where we are.
