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International Conference on Software Process Improvement and Capability Determination

SPICE 2015: Software Process Improvement and Capability Determination pp 13–18Cite as

Safety Critical Software Process Assessment: How MDevSPICE® Addresses the Challenge of Integrating Compliance and Capability

Part of the Communications in Computer and Information Science book series (CCIS,volume 526)

Abstract

One of the primary outcomes of a software process assessment is visibility of the capability of a software process which among other things, informs us of the ability of a process to deliver consistent product quality levels. In safety critical domains, such as the medical device sector, high product quality – and particularly high product safety - is an important consideration. To address this safety concern, the medical device sector traditionally employs audits to determine compliance to software process standards and guidance. Unlike an audit which results in a pass/fail outcome, an assessment provides a process capability profile which identifies areas for improvement and enables a comparison with broader best practice. MDevSPICE® integrates the various medical device software standards and guidance within the infrastructure of a SPICE assessment model, thus encompassing aspects of compliance and capability. This paper describes some of the key enablers of this integration.

Keywords

  • Safety critical software
  • Medical device software
  • Software process improvement
  • Software process assessment
  • MDevSPICE®

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Author information

Authors and Affiliations

  1. Regulated Software Research Centre, Dundalk Institute of Technology, Dundalk, Ireland

    Paul Clarke, Marion Lepmets, Alec Dorling & Fergal McCaffery

Authors
  1. Paul Clarke
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  2. Marion Lepmets
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  3. Alec Dorling
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  4. Fergal McCaffery
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Corresponding author

Correspondence to Paul Clarke .

Editor information

Editors and Affiliations

  1. Griffith University, Brisbane, Queensland, Australia

    Terry Rout

  2. Dublin City University, Dublin, Ireland

    Rory V. O’Connor

  3. Impronova AB, Lindome, Sweden

    Alec Dorling

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Clarke, P., Lepmets, M., Dorling, A., McCaffery, F. (2015). Safety Critical Software Process Assessment: How MDevSPICE® Addresses the Challenge of Integrating Compliance and Capability. In: Rout, T., O’Connor, R., Dorling, A. (eds) Software Process Improvement and Capability Determination. SPICE 2015. Communications in Computer and Information Science, vol 526. Springer, Cham. https://doi.org/10.1007/978-3-319-19860-6_2

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  • DOI: https://doi.org/10.1007/978-3-319-19860-6_2

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-19859-0

  • Online ISBN: 978-3-319-19860-6

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