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How Can Software SMEs Become Medical Device Software SMEs

  • Fergal McCaffery
  • Valentine Casey
  • Martin McHugh
Part of the Communications in Computer and Information Science book series (CCIS, volume 172)

Abstract

The amount of software content within medical devices has grown considerably over recent years and will continue to do so as the level of complexity of medical devices increase. This is driven by the fact that software is introduced to produce sophisticated medical devices that would not be possible using only hardware. This therefore presents opportunities for software development SMEs to become medical device software development organisations. However, some obstacles need to be addressed and overcome in order to make the transition from being a generic software development organisation to becoming a medical device software development organisation. This paper describes these obstacles and how research that is currently being performed within the Regulated Software Research Group in Dundalk Institute of Technology may be used to assist with this transition.

Keywords

Medical device software Software development Software process improvement and assessment Medi SPICE Medical device standards SME’s 

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Copyright information

© Springer-Verlag Berlin Heidelberg 2011

Authors and Affiliations

  • Fergal McCaffery
    • 1
  • Valentine Casey
    • 1
  • Martin McHugh
    • 1
  1. 1.Regulated Software Research GroupDundalk Institute of Technology & LeroDundalkIreland

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