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To what extent the medical device software regulations can be achieved with agile software development methods? XP—DSDM—Scrum

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Abstract

For medical device software development organizations, it is very challenging to maintain both conformance to the strict regulatory requirements enforced by the safety-critical nature of the domain and achieve efficiency in software development. Agile software development methods provide promising solutions to overcome the efficiency issues and the challenges of traditional software development approaches in the domain. Previously, we investigated to what extent the regulatory requirements defined in MDevSPICE® (the software process assessment framework for medical device software development) are met through using eXtreme Programming (XP) and Scrum and what additional practices have to be performed to ensure safety and regulatory compliance in the medical device software development domain. In this paper, we extended the research to include the Dynamic Systems Development Method (DSDM) which covers the whole software development life cycle. Here, we provide a comprehensive and quantitative analysis of XP’s and DSDM’s suitability for medical device software development and briefly discuss Scrum from the same perspective. We provide the coverage ratios of processes and practices defined in MDevSPICE® when these agile software development methods are implemented.

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Acknowledgements

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, Dundalk Institute of Technology, Dundalk, Ireland

    Özden Özcan-Top & Fergal McCaffery

  2. Lero, The Irish Software Engineering Research Centre, Limerick, Ireland

    Özden Özcan-Top & Fergal McCaffery

  3. STATSports Group, Newry, Ireland

    Fergal McCaffery

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  1. Özden Özcan-Top
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  2. Fergal McCaffery
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Correspondence to Özden Özcan-Top.

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Özcan-Top, Ö., McCaffery, F. To what extent the medical device software regulations can be achieved with agile software development methods? XP—DSDM—Scrum. J Supercomput 75, 5227–5260 (2019). https://doi.org/10.1007/s11227-019-02793-x

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