Challenges experienced by Medical Device Software Development Organizations while following a Plan-Driven Software Development Life Cycle

Mc Hugh, Martin and McCaffery, Fergal (2013) Challenges experienced by Medical Device Software Development Organizations while following a Plan-Driven Software Development Life Cycle. In: EuroSPI 2013, 25-27 June, Dundalk, Ireland.

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Abstract

Medical device software organisations face challenges not faced by generic software devel-opment organisations. These challenges include the adherence to regulatory controls. Regula-tory 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 re-quire 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 delivera-bles. Despite not dictating which SDLC must be followed when developing medical device software, organisations typically develop their software in accordance with a Plan-Driven soft-ware 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.

Item Type:	Conference or Workshop Item (Paper)
Uncontrolled Keywords:	Medical software; Medical device software; SDLC
Subjects:	Computer Science
Research Centres:	Regulated Software Research Centre
Depositing User:	Martin McHugh
Date Deposited:	10 Apr 2013 15:02
Last Modified:	11 Nov 2014 16:10
URI:	https://eprints.dkit.ie/id/eprint/310

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