
Medical Software Life Cycles: Agile Development
In this lecture from Yale's Introduction to Medical Software, the instructor examines how modern agile development methodologies can be integrated with the life cycle processes defined by the IEC 62304 standard introduced in the previous session. The session addresses the apparent tension between agile's iterative, flexible approach and the documentation-heavy, staged requirements of regulated medical software development, and shows how teams reconcile the two in practice. Students learn which agile practices adapt well to a regulated environment and which require modification to satisfy compliance obligations. The lecture gives students a practical understanding of how contemporary software teams actually organize their work while still meeting the standards covered throughout the course.