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

  • Celestina Bianco
Conference paper

Abstract

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.

Keywords

Medical Device Quality System Change Request Medical Software Risk Management Process 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

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

Copyright information

© Springer-Verlag London Limited 2011

Authors and Affiliations

  • Celestina Bianco
    • 1
  1. 1.Systelab TechnologiesBarcelonaSpain

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