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Challenges experienced by medical device software development organizations while following a plan-driven software development life cycle
Mc Hugh, Martin; Mc Caffery, Fergal
Medical device software organisations face challenges not faced by generic software development organisations. These challenges include the adherence to regulatory controls. Regulatory bodies require medical device software organisations to provide objective evidence that the software they are developing is safe and reliable. To produce this, regulatory bodies require a number of deliverables which must be achieved. However, they do not dictate which Software Development Life Cycle (SDLC) must be followed in order to achieve these deliverables. Despite not dictating which SDLC must be followed when developing medical device software, organisations typically develop their software in accordance with a Plan-Driven software development lifecycle. By conducting semi structured interviews with seven medical device software organisations, we gained a deeper insight into how the challenges experienced impact on the development of medical device software. The interviews also attempted to learn from the participants how they believe the challenges experienced can be overcome. The aim of this paper is to explain the methodology used to perform interviews with medical device software organisations and to present these interviews.
Keyword(s): medical device; FDA; agile; software development life cycle; semi-structured interview
Publication Date:
2013
Type: Conference item
Peer-Reviewed: Yes
Language(s): English
Institution: University of Limerick
Funder(s): Science Foundation Ireland
Citation(s): EuroSPI;
07/SK/I1299
08/IN.1/I2030
10/CE/I1855
Publisher(s): EuroSPI 2013
First Indexed: 2014-09-25 05:37:34 Last Updated: 2019-09-19 06:26:02