Agile – Is it Suitable for Medical Device Software Development?

  • Fergal McCaffery
  • Kitija Trektere
  • Ozden Ozcan-Top
Conference paper
Part of the Communications in Computer and Information Science book series (CCIS, volume 609)

Abstract

Medical device software is typically developed through adopting a prescribed plan driven software development lifecycle approach based upon variations of the waterfall or V-Model. Organisations wishing to satisfy regulations have to define software development processes and also that these processes have been implemented throughout the complete development lifecycle. Agile development techniques report to offer solutions within other industries that would solve challenges encountered within the medical device industry. However, there are some concerns with using agile for medical device software development in relation to satisfying the regulatory bodies. In this short paper, we highlight the issues in traditional medical device software development. Secondly, we discuss the challenges and highlight agile practices that have been successfully adopted in the medical device software industry.

Keywords

Medical device Agile software development Plan driven V–model 

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Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • Fergal McCaffery
    • 1
  • Kitija Trektere
    • 1
  • Ozden Ozcan-Top
    • 1
  1. 1.Regulated Software Research CentreDundalk Institute of TechnologyDundalkIreland

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