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International Conference on Software Process Improvement and Capability Determination

SPICE 2017: Software Process Improvement and Capability Determination pp 257–268Cite as

How Does Scrum Conform to the Regulatory Requirements Defined in MDevSPICE®?

Part of the Communications in Computer and Information Science book series (CCIS,volume 770)

Abstract

Medical device software development is subject to high regulations due to the potential risk of harming patients with unsafe medical devices. These regulations require software development to be performed with high discipline and evidence to be provided for auditory purposes. It’s not easy to manage both conformance to regulations and efficiency in medical device development. Therefore, there is a transition towards agility in safety critical systems development, to build high quality systems, shorten time to market, improve customer and employee satisfaction and ensure both safety and reliability. In this study, we evaluated one of the most highly adopted agile software development methods, Scrum from a regulatory perspective. We investigated to what extend the regulatory requirements defined in MDevSPICE® are met with implementation of the Scrum method and what additional processes and practices have to be performed to ensure safety and regulatory compliance in the healthcare domain.

Keywords

  • MDevSPICE®
  • Scrum
  • Regulatory compliance
  • Safety critical domain
  • Agile software development

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Acknowledgement

This research is supported by Science Foundation Ireland under a co-funding initiative by the Irish Government and European Regional Development Fund through Lero - the Irish Software Research Centre (http://www.lero.ie) grant 13/RC/2094. This research is also partially supported by the EU Ambient Assisted Living project – Maestro.

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Authors and Affiliations

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

    Özden Özcan-Top & Fergal McCaffery

  2. STATSports Group, Dundalk, Ireland

    Fergal McCaffery

Authors
  1. Özden Özcan-Top
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  2. Fergal McCaffery
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Corresponding author

Correspondence to Özden Özcan-Top .

Editor information

Editors and Affiliations

  1. University of the Balearic Islands, Palma, Spain

    Antonia Mas

  2. University of the Balearic Islands, Palma, Baleares, Spain

    Antoni Mesquida

  3. Dublin University, Dublin, Ireland

    Prof. Dr. Rory V. O'Connor

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

    Terry Rout

  5. Impronova AB, Askim, Sweden

    Alec Dorling

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Özcan-Top, Ö., McCaffery, F. (2017). How Does Scrum Conform to the Regulatory Requirements Defined in MDevSPICE®?. In: Mas, A., Mesquida, A., O'Connor, R., Rout, T., Dorling, A. (eds) Software Process Improvement and Capability Determination. SPICE 2017. Communications in Computer and Information Science, vol 770. Springer, Cham. https://doi.org/10.1007/978-3-319-67383-7_19

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  • DOI: https://doi.org/10.1007/978-3-319-67383-7_19

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-67382-0

  • Online ISBN: 978-3-319-67383-7

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