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Software process improvement roadmaps – using design patterns to aid SME’s developing medical device software in the implementation of IEC 62304
Rust, Peter; Flood, Derek; Mc Caffery, Fergal
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 or-der 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
Keyword(s): SME’s; medical device software; medical device standards; regulatory compliance; software roadmap; software process improvement; software process improvement roadmaps; IEC 62304; design patterns
Publication Date:
Type: Conference item
Peer-Reviewed: Yes
Language(s): English
Institution: University of Limerick
Funder(s): Science Foundation Ireland
Citation(s): 16th International Conference, SPICE 2016: Communications in Computer and Information Science;609, pp. 43-56
Publisher(s): Springer
First Indexed: 2019-09-19 06:26:45 Last Updated: 2019-09-19 06:26:45