How does Scrum Conform to the Regulatory Requirements Defined in MDevSPICE?

McCaffery, Fergal and Ozcantop, Ozden (2017) How does Scrum Conform to the Regulatory Requirements Defined in MDevSPICE? In: Software Process Improvement and Capability Determination. Communications in Computer and Information Science, 770 . Springer, Berlin, pp. 257-268. ISBN 9783319673837

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Abstract

Medical device software development is subject to high regulations due to the potential risk of harming patients with unsafe medical devices. These regulations require software development to be performed with high discipline and evidence to be provided for auditory purposes. It’s not easy to manage both conformance to regulations and efficiency in medical device development. Therefore, there is a transition towards agility in safety critical systems development, to build high quality systems, shorten time to market, improve customer and employee satisfaction and ensure both safety and reliability. In this study, we evaluated one of the most highly adopted agile software development methods, Scrum from a regulatory perspective. We investigated to what extend the regulatory requirements defined in MDevSPICE® are met with implementation of the Scrum method and what additional processes and practices have to be performed to ensure safety and regulatory compliance in the healthcare domain.

Item Type:	Book Section
Uncontrolled Keywords:	MDevSPICE®; Scrum; Regulatory Compliance; Safety Critical Domain; Agile Software Development.
Subjects:	Computer Science Computer Science > Computer Software
Research Centres:	Regulated Software Research Centre
Depositing User:	Enda Kelly
Date Deposited:	28 Nov 2018 10:22
Last Modified:	28 Nov 2018 10:22
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/595

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