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To what extent the medical device software regulations can be achieved with agile software development methods? XP-DSDM-Scrum
Date
2019-08-01
Author
Özcan Top, Özden
Metadata
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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 (R) (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 (R) when these agile software development methods are implemented.
Subject Keywords
Agile software development
,
Safety-critical domain
,
Scrum
,
DSDM
,
MDevSPICE (R)
,
Medical software
,
Medical domain
,
XP
URI
https://hdl.handle.net/11511/31935
Journal
JOURNAL OF SUPERCOMPUTING
DOI
https://doi.org/10.1007/s11227-019-02793-x
Collections
Graduate School of Informatics, Article
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Ö. Özcan Top, “To what extent the medical device software regulations can be achieved with agile software development methods? XP-DSDM-Scrum,”
JOURNAL OF SUPERCOMPUTING
, pp. 5227–5260, 2019, Accessed: 00, 2020. [Online]. Available: https://hdl.handle.net/11511/31935.