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Improving Verification & Validation in the Medical Device Domain

  • Conference paper
Systems, Software and Service Process Improvement (EuroSPI 2011)

Part of the book series: Communications in Computer and Information Science ((CCIS,volume 172))

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Abstract

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.

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Author information

Authors and Affiliations

  1. Regulated Software Research Group, Dundalk Institute of Technology & Lero, Ireland

    M. S. Sivakumar, Valentine Casey, Fergal McCaffery & Gerry Coleman

Authors
  1. M. S. Sivakumar
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  2. Valentine Casey
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  3. Fergal McCaffery
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  4. Gerry Coleman
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Editor information

Editors and Affiliations

  1. Lero, The Irish Software Engineering Research Centre, School of Computing, Dublin City University, Dublin, Ireland

    Rory V. O‘Connor

  2. Roskilde University, Roskilde, Denmark

    Jan Pries-Heje

  3. ISCN Ltd., Graz, Austria

    Richard Messnarz

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© 2011 Springer-Verlag Berlin Heidelberg

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Sivakumar, M.S., Casey, V., McCaffery, F., Coleman, G. (2011). Improving Verification & Validation in the Medical Device Domain. In: O‘Connor, R.V., Pries-Heje, J., Messnarz, R. (eds) Systems, Software and Service Process Improvement. EuroSPI 2011. Communications in Computer and Information Science, vol 172. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-22206-1_6

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  • DOI: https://doi.org/10.1007/978-3-642-22206-1_6

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-22205-4

  • Online ISBN: 978-3-642-22206-1

  • eBook Packages: Computer ScienceComputer Science (R0)

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