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

Show full item record

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Item Usage Stats

219
views

0
downloads

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

Suggestions

OpenMETU
Core

A Lightweight Software Process Assessment Approach Based on MDevSPICE((R)) for Medical Device Development Domain Özcan Top, Özden (2017-09-04) Software process improvement is challenging in the medical device development domain, as significant constraints exist such as ensuring conformance to regulations while improving software quality. The regulations that medical products are subject to may be overwhelming for organisations as a variety of international standards have to be implemented in order to address regulatory compliance. MDevSPICE® is a framework developed to overcome this challenge by integrating different international regulatory stand...
Using feature models for reusability in agile methods Jedyk, Marcin; Doğru, Ali Hikmet; Department of Computer Engineering (2011) The approach proposed in this thesis contributes to implementing source code reuse and re-engineering techniques for agile software development. This work includes an introduction to feature models and some of the Feature Oriented Software Development (FOSD) practices to achieve a lightweight way of retrieving source code. A Feature model created during the course of following FOSD practices serves as an additional layer of documentation which represents the problem space for the developed application. This...
An Ontology based approach to requirements reuse problem in software product lines Karataş, Elif Kamer; Birtürk, Ayşenur; Department of Computer Engineering (2012) With new paradigms in software engineering such as Software Product Lines, scope of reuse is enlarged from implementation upto design, requirements, test-cases, etc. In this thesis an ontology-based approach is proposed as a solution to systematic requirement reuse problem in software product lines, and the approach is supported with a reuse automation tool. A case study is performed on the projects of an industrial software product line using hereby proposed solution and then based on the evaluated metrics...
Metamodeling of Reference Software Architecture and Automatic Code Generation Turhan, Nafiye Kubra; Oğuztüzün, Mehmet Halit S. (2016-12-02) Architectures of all application software that are developed by Sea Defense Systems Software Team in ASELSAN are created based on a predefined reference software architecture. In order to facilitate the process of transition from the software architectural design, which is created in conformance with the reference software architecture, to implementation a model driven software development approach is put forth. In this approach, based on a metamodel for the predefined reference software architecture, a dom...
Evaluation of Agility Assessment Tools: A Multiple Case Study Adali, Onat Ege; Özcan Top, Özden; Demirors, Onur (2016-06-10) Agile software development has been one of the most important paradigms of software engineering community. Agile methods that are shaped around Agile Manifesto and principles, provide promising results when applied properly in software organizations. Agile assessment models and tools have potential to indicate agile adoption problems at project level or organization level. In the scope of this study, we identified 37 agility assessment tools. Among those tools, we evaluated 11 agility assessment tools based...

Citation Formats

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.