Certification of Software-Driven Medical Devices

  • Mark Lawford
  • Tom Maibaum
  • Alan Wassyng
Part of the Lecture Notes in Computer Science book series (LNCS, volume 6416)

Abstract

This track focuses on the issue of certification for modern medical devices. These devices rely more and more on software and are paradigmatic examples of safety critical systems. Existing approaches to software safety and certification are invariably process based; at best, this gives us only indirect, statistical evidence of safety. Thus, they do not offer the kinds of product based guarantees expected by engineers in other classical disciplines as a basis for product certification. This track focuses on the state of the art and proposals for improvement in this crucial area of research. The track includes four papers on relevant topics and a panel discussing the crucial scientific issues involved in making certification judgements.

Keywords

software certification safety critical systems safety cases assurance cases formal methods medical devices 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Hatcliff, J., Heimdahl, M., Lawford, M., Maibaum, T., Wassyng, A., Wurden, F.: A software certification consortium and its top 9 hurdles. In: SafeCert 2008 Proceedings (2008) (to appear in ENTCS)Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2010

Authors and Affiliations

  • Mark Lawford
    • 1
  • Tom Maibaum
    • 1
  • Alan Wassyng
    • 1
  1. 1.McMaster Centre for Software Certification, Department of Computing and SoftwareMcMaster UniversityHamiltonCanada

Personalised recommendations