Risk Management Process Improvement for the Medical Device Industry

F McCaffery, D McFall, FG Wilkie

Research output: Chapter in Book/Report/Conference proceedingConference contribution

Abstract

Abstract. This paper outlines a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as MedeSPI – Medical Devices Software Process Improvement) will address an opportunity to integrate the regulatory issues and process improvement mechanisms in order to achieve improved software processes within a number of process areas that are critical to the development of software for medical devices [3]. The paper then describes in detail how the goals, practices and capability levels for the risk management process area within the MedeSPI framework have been developed.
Original languageEnglish
Title of host publicationUnknown Host Publication
Place of PublicationReykjavik
PublisherUniversitatis Islandiae
Pages92-103
Number of pages11
ISBN (Print)9979-54648-4
Publication statusPublished - May 2005
EventInternational Conference on Software Development - Universiry of Iceland, Iceland
Duration: 1 May 2005 → …

Conference

ConferenceInternational Conference on Software Development
Period1/05/05 → …

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  • Cite this

    McCaffery, F., McFall, D., & Wilkie, FG. (2005). Risk Management Process Improvement for the Medical Device Industry. In Unknown Host Publication (pp. 92-103). Universitatis Islandiae. http://www.3swdc.hi.is/index.html