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

Özcan-Top , Özden and McCaffery, Fergal (2019) To what extent the medical device software regulations can be achieved with agile software development methods? XP—DSDM—Scrum. The Journal of Supercomputing, 75 (8). 5227-5260. ISSN 0920-8542

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Abstract

For medical device software development organisations, 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 XP (eXtreme Programming) 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.

Item Type:	Article
Subjects:	Computer Science > Computer Software
Research Centres:	Regulated Software Research Centre
Depositing User:	Roisin Loughran
Date Deposited:	21 Jan 2020 09:02
Last Modified:	21 Jan 2020 09:02
URI:	https://eprints.dkit.ie/id/eprint/665

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