Agile can give superior results for the development of infusion pumps and clinical diagnostic systems as well web sites and games. But although Agile adoption in a regulated environment seems simple, it is not easy. It requires investment in process, true collaboration among all functions, and servant leadership from management. Agile developers need to be aware of requirements and design documentation, traceability, risk management, and technical reviews in a regulated context. This presentation will cover those topics and others that may be new to many Agile developers: Mutual learning where development involves hardware and electronics Developing user stories for . . .