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International Conference on Software Process Improvement and Capability Determination

SPICE 2016: Software Process Improvement and Capability Determination pp 417–422Cite as

Agile – Is it Suitable for Medical Device Software Development?

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Part of the book series: Communications in Computer and Information Science ((CCIS,volume 609))

Abstract

Medical device software is typically developed through adopting a prescribed plan driven software development lifecycle approach based upon variations of the waterfall or V-Model. Organisations wishing to satisfy regulations have to define software development processes and also that these processes have been implemented throughout the complete development lifecycle. Agile development techniques report to offer solutions within other industries that would solve challenges encountered within the medical device industry. However, there are some concerns with using agile for medical device software development in relation to satisfying the regulatory bodies. In this short paper, we highlight the issues in traditional medical device software development. Secondly, we discuss the challenges and highlight agile practices that have been successfully adopted in the medical device software industry.

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Acknowledgments

This research is supported by the SFI through Lero - the Irish Software Research Centre (http://www.lero.ie) grant 10/CE/I1855 & 13/RC/20194.

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Authors and Affiliations

  1. Regulated Software Research Centre, Dundalk Institute of Technology, Dublin Road, Dundalk, Co.Louth, Ireland

    Fergal McCaffery, Kitija Trektere & Ozden Ozcan-Top

Authors
  1. Fergal McCaffery
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  2. Kitija Trektere
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  3. Ozden Ozcan-Top
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Corresponding author

Correspondence to Fergal McCaffery .

Editor information

Editors and Affiliations

  1. Lero Irish Software Research Centre, Dublin City University Lero Irish Software Research Centre, Dublin, Ireland

    Paul M. Clarke

  2. Dublin City University , Dublin 9, Ireland

    Rory V. O'Connor

  3. Software Quality Institue, Griffith University Software Quality Institue, Brisbane, Queensland, Australia

    Terry Rout

  4. Impronova AB , Drabergsvagen, Lindome, Sweden

    Alec Dorling

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© 2016 Springer International Publishing Switzerland

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McCaffery, F., Trektere, K., Ozcan-Top, O. (2016). Agile – Is it Suitable for Medical Device Software Development?. In: Clarke, P., O'Connor, R., Rout, T., Dorling, A. (eds) Software Process Improvement and Capability Determination. SPICE 2016. Communications in Computer and Information Science, vol 609. Springer, Cham. https://doi.org/10.1007/978-3-319-38980-6_30

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  • DOI: https://doi.org/10.1007/978-3-319-38980-6_30

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-38979-0

  • Online ISBN: 978-3-319-38980-6

  • eBook Packages: Computer ScienceComputer Science (R0)

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