IEC 62304 defines the life cycle requirements for medical device software as it is often an integral part of the device’s technology. Establishing the safety and effectiveness of a medical device containing software requires knowledge of what the software is intended to do and demonstration that the use of the software fulfils those intentions without causing any unacceptable risks.
IEC 62304 provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. It provides requirements for each life cycle process. Each life cycle process is further divided into a set of activities, with most activities further divided into a set of tasks.
As a foundation, it is assumed that medical device software is developed and maintained within a quality management system and a risk management system. EN 62304:2006/A1:2015 is intended to add requirements to deal with legacy software. The text of IEC 62304:2006 has been approved in Europe as EN 62304:2006 without any modification.