Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304

Rust, Peter and Flood, Derek and McCaffery, Fergal (2015) Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304. Communications in Computer and Information Science, 609. ISSN 1865-0929

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Abstract

One stated objective of the European Union is to encourage SME’s expand their area of operation into other domains. The medical device domain is one such domain identified by the EU. Medical device software development must be carried out in a manner that compliance with certain medical device standards and regulations can be demonstrated. IEC 62304, Medical device software - software life cycle processes, is a standard that defines the processes that are required to be executed in order to develop safe software. SME software development organizations wishing to expand their operations into the medical device software development domain face serious challenges in demonstrating compliance with IEC 62304. The standard describes the set of processes, activities, and tasks that are required to be carried out, but importantly do not describe how they should be carried out. This paper describes the development of a roadmap that will aid software development SME’s, entering the medical device software development domain, by the use of design patterns to generate “How-to” artefacts, overcome the challenge of demonstrating compliance.

Item Type:	Article
Uncontrolled Keywords:	SME’s; Medical device software; Medical device standards; Regulatory compliance; Software roadmap Software process improvement; Software process improvement roadmaps; IEC 62304; Design patterns.
Subjects:	Computer Science > Computer Software
Research Centres:	Regulated Software Research Centre
Depositing User:	Sean McGreal
Date Deposited:	11 Nov 2016 14:54
Last Modified:	11 Nov 2016 14:54
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/548

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