An Agile Implementation within a Medical Device Software Organisation

  • Martin McHugh
  • Fergal McCaffery
  • Garret Coady
Part of the Communications in Computer and Information Science book series (CCIS, volume 477)


Three surveys conducted over a 6 year period revealed that medical device software organisations have difficulties in the area of requirements management, namely accommodating changes in requirements. Medical device software is traditionally developed in accordance with a plan driven software development lifecycle (SDLC). These SDLCs are rigid and inflexible to changes once the requirements management stage has been completed. Agile methods are gaining momentum in non-regulated industries but as of yet, the adoption of these methods in regulated industries such as the medical device software domain remains low. This study presents an implementation of agile methods within a medical device software development organisation based in Ireland. This implementation involved integrating agile practices with a traditional plan driven SDLC. Upon completing this implementation within a medical device software development project, the organisation identified cost savings and a reduction in the rework required when introducing a change in requirements.


Agile SDLC Medical AV-Model Hybrid IEC 62304 


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Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  • Martin McHugh
    • 1
  • Fergal McCaffery
    • 1
  • Garret Coady
    • 2
  1. 1.Regulated Software Research CentreDundalk Institute of TechnologyDundalkIreland
  2. 2.BlueBridge TechnologiesDublinIreland

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