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

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journal contribution
posted on 2024-03-28, 09:16 authored by Özden Özcan-Top, Fergal McCaffery

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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The Journal of Supercomputing, 2019,75, 5227–5260




This version of the article has been accepted for publication, but is not the Version of Record and does not reflect postacceptance improvements, or any corrections. The Version of Record is available online at: Use of this Accepted Version is subject to the publisher’s Accepted Manuscript terms of use

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