Improving Verification & Validation in the Medical Device Domain

  • M. S. Sivakumar
  • Valentine Casey
  • Fergal McCaffery
  • Gerry Coleman
Conference paper
Part of the Communications in Computer and Information Science book series (CCIS, volume 172)


The benefits of effective verification and validation activities in the medical device domain include increased usability and reliability, decreased failure rate and recalls and reduced risks to patients and users. Though there is guidance on verification and validation in multiple standards in the medical device domain, these are difficult for the manufacturer to implement, as there is no consolidated information on how they can be successfully achieved. The paper is intended to highlight three major areas for improvement in the medical device software development domain. This research is based on an analysis of available literature in the field of verification and validation in generic software development, safety-critical and medical device software domains. Additionally, we also performed a review of the standards and process improvement models available in these domains.


Medical device standards Medical device software verification and validation V&V Medical device software process assessment and improvement Medi SPICE 


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Copyright information

© Springer-Verlag Berlin Heidelberg 2011

Authors and Affiliations

  • M. S. Sivakumar
    • 1
  • Valentine Casey
    • 1
  • Fergal McCaffery
    • 1
  • Gerry Coleman
    • 1
  1. 1.Regulated Software Research GroupDundalk Institute of Technology & LeroIreland

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