Integrating a Risk-based Approach and ISO 62304 into a Quality System for Medical Devices

A recent standard for medical device software lifecycle processes, ISO/IEC 62304 (ISO 2006), assumes and specifies a software safety classification scheme, where documentation, verification and validation tasks to be carried out depend on the safety classification. This means that a risk-driven approach has become an accepted standard for medical devices. This paper describes how Systelab have progressively defined a quality system that integrates as core processes those specified by ISO 62304, and that applies a risk-driven approach also supporting processes such as contract and supplier management.