The IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package specifies the process of identifying, controling and monitoring risk and hazards associated with medical device software. It also defines the life cycle requirements for medical device software, set of processes, activities, and tasks establishing a common framework for medical device software life cycle processes. IEC 62304 / IEC/TR 80002-1 / ISO 14971 Medical Devices Software Package is applicable to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. It includes ISO 14971:2007
, IEC 62304 Ed. 1.1 en:2015 and IEC/TR 80002-1 Ed. 1.0 en:2009.