AAMI/IEC TIR80002-3:2016

Software is often an integral part of medical device technology. Establishing the safety and effectiveness of a medical device containing software requires well designed software that fulfils its purpose without causing any unacceptable risks. Following an internationally approved set of software development practices provides one way of achieving this. This technical report (TR) provides a framework of life cycle processes supporting the safe design and maintenance of medical device software called the process reference model (PRM). The process descriptions in this PRM are fully compliant with the requirements of ISO/IEC 24774:2010, Systems and software engineering — Life cycle management — Guidelines for process description. This TR presents the PRM for medical device software development as a result of integrating requirements from IEC 62304:2006 and from the international standard of software life-cycle processes ISO/IEC 12207:2008. Annex 3