Software development life cycle model

IEC 62304 does not require a specific model, so waterfall, iterative and agile approaches all work. The model chosen has to be described in the software development plan.

conceptual structure spanning the life of the software from definition of its requirements to its release, which: – identifies the PROCESS, ACTIVITIES and TASKS involved in development of MEDICAL DEVICE SOFTWARE, – describes the sequence of and dependency between ACTIVITIES and TASKS, and – identifies the milestones at which the completeness of specified DELIVERABLES is verified. NOTE Based on ISO/IEC 12207:1995, definition 3.11

IEC 62304:2006+AMD1:2015, clause 3.24