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Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304

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Software Process Improvement and Capability Determination (SPICE 2016)

Part of the book series: Communications in Computer and Information Science ((CCIS,volume 609))

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Abstract

One stated objective of the European Union is to encourage SME’s expand their area of operation into other domains. The medical device domain is one such domain identified by the EU. Medical device software development must be carried out in a manner that compliance with certain medical device standards and regulations can be demonstrated. IEC 62304, Medical device software - software life cycle processes, is a standard that defines the processes that are required to be executed in order to develop safe software. SME software development organizations wishing to expand their operations into the medical device software development domain face serious challenges in demonstrating compliance with IEC 62304. The standard describes the set of processes, activities, and tasks that are required to be carried out, but importantly do not describe how they should be carried out. This paper describes the development of a roadmap that will aid software development SME’s, entering the medical device software development domain, by the use of design patterns to generate “How-to” artefacts, overcome the challenge of demonstrating compliance.

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Acknowledgement

This research is supported by the Science Foundation Ireland Principal Investigator Programme, grant number 08/IN.1/I2030 and by Lero - the Irish Software Research Centre (http://www.lero.ie) grant 10/CE/I1855 & 13/RC/20194.

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Authors and Affiliations

  1. Regulated Software Research Centre and Lero, Dundalk Institute of Technology, Dundalk, Ireland

    Peter Rust, Derek Flood & Fergal McCaffery

Authors
  1. Peter Rust
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  2. Derek Flood
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  3. Fergal McCaffery
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Corresponding author

Correspondence to Peter Rust .

Editor information

Editors and Affiliations

  1. Lero Irish Software Research Centre, Dublin City University Lero Irish Software Research Centre, Dublin, Ireland

    Paul M. Clarke

  2. Dublin City University , Dublin 9, Ireland

    Rory V. O'Connor

  3. Software Quality Institue, Griffith University Software Quality Institue, Brisbane, Queensland, Australia

    Terry Rout

  4. Impronova AB , Drabergsvagen, Lindome, Sweden

    Alec Dorling

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Rust, P., Flood, D., McCaffery, F. (2016). Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304. In: Clarke, P., O'Connor, R., Rout, T., Dorling, A. (eds) Software Process Improvement and Capability Determination. SPICE 2016. Communications in Computer and Information Science, vol 609. Springer, Cham. https://doi.org/10.1007/978-3-319-38980-6_4

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  • DOI: https://doi.org/10.1007/978-3-319-38980-6_4

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-38979-0

  • Online ISBN: 978-3-319-38980-6

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