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Computer and Information Science pp 127–140Cite as

Generation of Assurance Cases for Medical Devices

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Part of the book series: Studies in Computational Intelligence ((SCI,volume 566))

Abstract

In safety critical systems, the manufacturers should provide compelling and comprehensible arguments to demonstrate that their system is well designed and safety of the system to the public is guaranteed. These arguments are usually represented by an assurance case. However, one of challenging issues facing the safety critical industry is how to produce an assurance case that provides a set of well-structured arguments connecting safety requirements and a body of evidence produced during software development. In this paper, we take the medical systems industry into account to illustrate how an assurance case can be generated when a software process is employed. In particularly, we consider the Generic Insulin infusion Pump (GIIP) to show how an assurance case can be produced via during a popular software development process, called Rational Unified Process (RUP).

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Author information

Authors and Affiliations

  1. Department of Computer Science, Western Michigan University, Kalamazoo, MI, USA

    Chung-Ling Lin & Wuwei Shen

Authors
  1. Chung-Ling Lin
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  2. Wuwei Shen
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Corresponding author

Correspondence to Chung-Ling Lin .

Editor information

Editors and Affiliations

  1. Software Engineering and Information Technology Institute, Central Michigan University, Mt. Pleasant, Michigan, USA

    Roger Lee

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© 2015 Springer International Publishing Switzerland

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Lin, CL., Shen, W. (2015). Generation of Assurance Cases for Medical Devices. In: Lee, R. (eds) Computer and Information Science. Studies in Computational Intelligence, vol 566. Springer, Cham. https://doi.org/10.1007/978-3-319-10509-3_10

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  • DOI: https://doi.org/10.1007/978-3-319-10509-3_10

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-10508-6

  • Online ISBN: 978-3-319-10509-3

  • eBook Packages: EngineeringEngineering (R0)

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