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Standalone Software as an Active Medical Device

  • Conference paper
Software Process Improvement and Capability Determination (SPICE 2011)

Part of the book series: Communications in Computer and Information Science ((CCIS,volume 155))

Abstract

With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active medical device. Consequently the methods used to ensure device safety and reliability needs to be reviewed. IEC 62304 is the current software development lifecycle framework followed by medical device software developers but important processes are beyond the scope of IEC 62304. These processes are covered by additional standards. However since the MDD became mandatory these additional standards are not comprehensive enough to ensure the reliability of an active medical device consisting of only software. By employing software process improvement techniques this software can be developed and validated to ensure it performs the required task in a safe and reliable way.

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Author information

Authors and Affiliations

  1. Regulated Software Research Group, Dundalk Institute of Technology & Lero, Dundalk, Co. Louth, Ireland

    Martin McHugh, Fergal McCaffery & Valentine Casey

Authors
  1. Martin McHugh
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  2. Fergal McCaffery
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  3. Valentine Casey
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Editor information

Editors and Affiliations

  1. Lero, The Irish Software Engineering Research Centre, School of Computing, Dublin City University, Dublin, Ireland

    Rory V. O’Connor

  2. Software Quality Institute, Griffith University, Brisbane, Queensland, Australia

    Terry Rout

  3. Regulated Software Research Group, Lero, The Irish Software Engineering Research Centre, Dundalk Institute of Technology, Dundalk, Ireland

    Fergal McCaffery

  4. InterSPICE Ltd, 23 King Street, CB1 1AH, Cambridge, UK

    Alec Dorling

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© 2011 Springer-Verlag Berlin Heidelberg

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McHugh, M., McCaffery, F., Casey, V. (2011). Standalone Software as an Active Medical Device. In: O’Connor, R.V., Rout, T., McCaffery, F., Dorling, A. (eds) Software Process Improvement and Capability Determination. SPICE 2011. Communications in Computer and Information Science, vol 155. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-21233-8_9

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  • DOI: https://doi.org/10.1007/978-3-642-21233-8_9

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-21232-1

  • Online ISBN: 978-3-642-21233-8

  • eBook Packages: Computer ScienceComputer Science (R0)

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