MDevSPICE - A Comprehensive Solution for Manufacturers and Assessors of Safety-Critical Medical Device Software

  • Paul Clarke
  • Marion Lepmets
  • Fergal McCaffery
  • Anita Finnegan
  • Alec Dorling
  • Derek Flood
Conference paper

DOI: 10.1007/978-3-319-13036-1_26

Part of the Communications in Computer and Information Science book series (CCIS, volume 477)
Cite this paper as:
Clarke P., Lepmets M., McCaffery F., Finnegan A., Dorling A., Flood D. (2014) MDevSPICE - A Comprehensive Solution for Manufacturers and Assessors of Safety-Critical Medical Device Software. In: Mitasiunas A., Rout T., O’Connor R.V., Dorling A. (eds) Software Process Improvement and Capability Determination. SPICE 2014. Communications in Computer and Information Science, vol 477. Springer, Cham

Abstract

Software development is frequently challenged with quality concerns. One of the primary reasons for such issues is the very nature of the software development process. First, it can be difficult to accurately and completely identify the requirements for a software development product. Also, the implementation on various platforms and the need to integrate with sometimes unforeseeable additional systems adds complexity. For safety critical domains, such as the medical device and healthcare sectors, these hurdles are amplified. Whereas a failure in a desktop application may be resolved through a restart with no harm incurred, a failure in a medical device can have life threatening consequences. Our work in the Regulated Software Research Centre (RSRC) aims to support medical device producers in the production of safer medical device software. In this paper, we describe the MDevSPICE framework and how it addresses the safety concerns faced by medical device producers.

Keywords

Medical Device Software Software Process Improvement Medical Device Software Process Assessment and Improvement MDevSPICE 

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Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  • Paul Clarke
    • 1
  • Marion Lepmets
    • 1
  • Fergal McCaffery
    • 1
  • Anita Finnegan
    • 1
  • Alec Dorling
    • 1
  • Derek Flood
    • 1
  1. 1.Regulated Software Research Centre, Dundalk Institute of TechnologyDundalkIreland

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