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Verification & Validation in Medi SPICE

  • M. S. Sivakumar
  • Valentine Casey
  • Fergal McCaffery
  • Gerry Coleman
Conference paper
  • 1.1k Downloads
Part of the Communications in Computer and Information Science book series (CCIS, volume 155)

Abstract

Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider process improvement initiatives. This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domain.

Keywords

Medical device standards Medical device software verification and validation Medical device software process assessment and improvement 

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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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