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MDevSPICE - A comprehensive solution for manufacturers and assessors of safety-critical medical device software
Clarke, Paul; Lepmets, Marion; McCaffery, Fergal; Finnegan, Anita
Software development is frequently challenged with quality concerns. One of the primary reasons for such issues is the very nature of the software development process. First, it can be difficult to accurately and completely identify the requirements for a software development product. Also, the implementation on various platforms and the need to integrate with sometimes unforeseeable additional systems adds complexity. For safety critical domains, such as the medical device and healthcare sectors, these hurdles are amplified. Whereas a failure in a desktop application may be resolved through a restart with no harm incurred, a failure in a medical device can have life threatening consequences. Our work in the Regulated Software Research Centre (RSRC) aims to support medical device producers in the production of safer medical device software. In this paper, we describe the MDevSPICE framework and how it addresses the safety concerns faced by medical device producers.
Keyword(s): Software engineering; Medical Device Software; Software Process Improvement; Medical Device Software Process Assessment and Improvement; MDevSPICE
Publication Date:
2014
Type: Other
Peer-Reviewed: Unknown
Language(s): English
Institution: Dublin City University
Citation(s): Clarke, Paul, Lepmets, Marion, McCaffery, Fergal and Finnegan, Anita (2014) MDevSPICE - A comprehensive solution for manufacturers and assessors of safety-critical medical device software. In: Software Process Improvement and Capability Determination. Communications in Computer and Information Science . Springer, pp. 274-278. ISBN 978-3-319-13036-1
Publisher(s): Springer
File Format(s): application/pdf
Related Link(s): http://doras.dcu.ie/21089/1/Clarke_et_al_MDevSPICE_-_A_Comprehensive_Solution_SPICE2014.pdf,
http://link.springer.com/chapter/10.1007/978-3-319-13036-1_26
First Indexed: 2016-02-06 05:05:12 Last Updated: 2020-02-05 06:20:00