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.
KeywordsMedical Device Quality System Change Request Medical Software Risk Management Process
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- FAA (2003) US. Department of Transportation Federal Aviation Administration – Order 8110.49 software approval guidelinesGoogle Scholar
- FDA (2002) General principles of software validation. US Food and Drug AdministrationGoogle Scholar
- IEC (2009) IEC/TR 80002. Guidance on the application of ISO 14971 to medical device softwareGoogle Scholar
- ISO (2006) ISO/IEC 62304 – Medical device software – Software life cycle processes. Edition 1.0Google Scholar
- ISO (2007) ISO 14971 – Medical devices – Application of risk management to medical devicesGoogle Scholar
- RTCA (1992) DO-178B Software considerations in airborne systems and equipment certificationGoogle Scholar