Challenges in the regulatory approval of medical cyber-physical systems

Oleg Sokolsky, Insup Lee, Mats Heimdahl

Research output: Chapter in Book/Report/Conference proceedingConference contribution

12 Scopus citations

Abstract

We are considering the challenges that regulators face in approving modern medical devices, which are software intensive and increasingly network enabled. We then consider assurance cases, which offer the means of organizing the evidence into a coherent argument demonstrating the level of assurance provided by a system, and discuss research directions that promise to make construction and evaluation of assurance cases easier and more precise. Finally, we discuss some recent trends that will further complicate the regulatory approval of medical cyber-physical systems.

Original languageEnglish (US)
Title of host publicationEmbedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11
Pages227-232
Number of pages6
DOIs
StatePublished - 2011
EventEmbedded Systems Week 2011, ESWEEK 2011 - 9th ACM International Conference on Embedded Software, EMSOFT'11 - Taipei, Taiwan, Province of China
Duration: Oct 9 2011Oct 14 2011

Publication series

NameEmbedded Systems Week 2011, ESWEEK 2011 - Proceedings of the 9th ACM International Conference on Embedded Software, EMSOFT'11

Other

OtherEmbedded Systems Week 2011, ESWEEK 2011 - 9th ACM International Conference on Embedded Software, EMSOFT'11
Country/TerritoryTaiwan, Province of China
CityTaipei
Period10/9/1110/14/11

Keywords

  • Assurance cases
  • CertFication
  • Medical cyber-physical systems
  • Virtual medical devices

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