A Lightweight Software Process Assessment Approach based on MDevSPICE® for Medical Device Development Domain

McCaffery, Fergal and Özcan-Top, Ozden (2017) A Lightweight Software Process Assessment Approach based on MDevSPICE® for Medical Device Development Domain. In: Systems, Software and Services Process Improvement. Communications in Computer and Information Science, 748 . Springer, pp. 578-588. ISBN 9783319642178

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Abstract

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 standards’ requirements with generic software development best practices. Keeping the complexity of the domain in mind, the formal process assessments performed based on MDevSPICE® are highly detailed and require significant resource and effort investment. With the MDevSPICE® lightweight software process assessment approach, we aim to obtain maximum benefit from an assessment within a limited time by assessing all processes within MDevSPICE®, specifying and presenting major issues in projects, prioritizing such issues and progressing to the improvement stage as early as possible. The approach has designed to be a solution to improve feedback time and motivation to move forward for software process improvement actions. In this experience paper, we describe the development of the lightweight MDevSPICE® assessment method and its implementation in four companies.

Item Type:	Book Section
Uncontrolled Keywords:	Lightweight Assessment; Medical Device Software Development; Regulatory Requirements; Safety Critical; MDevSPICE®.
Subjects:	Computer Science Computer Science > Computer Software
Research Centres:	Regulated Software Research Centre
Depositing User:	Enda Kelly
Date Deposited:	28 Nov 2018 10:20
Last Modified:	28 Nov 2018 10:20
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/594

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