Type

Conference Proceedings

Authors

Val Casey
Gilbert Regan
Fergal Mc Caffery
Derek Flood
Fergal McCaffery

Subjects

Computer Science

Topics
critical software computer science evaluation process medical devices software process improvement roadmaps software process improvement spi medical device directive computer software spi medical device standards

A critical evaluation of a methodology for the generation of software process improvement roadmaps (2014)

Abstract For medical device organisations to market their devices in specific geographic regions they must adhere to the regulations of that region. These regulations often recommend that organisations adhere to specific standards and guidance documents which specify “what” must be achieved without specifying “how” this may be done. Due to changes to the medical device directive, which governs the development of medical devices within the EU, in March 2010, software can now in its own right be considered a medical device. This change has meant that a number of software organisations developing software for the medical device domain must now adhere to the same regulations as other medi-cal device manufacturers. In this work we present a concept for a Software Pro-cess Improvement (SPI) roadmap to guide such organisations through the task of implementing medical device standards and guidance documents. In addition we present and evaluate a methodology that can be used to create a SPI roadmap from a set of requirements such as the aforementioned standards and guidance documents.
Collections Ireland -> Dundalk IT -> Subject = Computer Science
Ireland -> University of Limerick -> Faculty of Science and Engineering
Ireland -> Dundalk IT -> Open Access DRIVERset
Ireland -> Dundalk IT -> Status = Published
Ireland -> University of Limerick -> LERO - The Irish Software Research Centre
Ireland -> Dundalk IT -> Type = Conference or Workshop Item
Ireland -> University of Limerick -> LERO - Project partner authors

Full list of authors on original publication

Val Casey, Gilbert Regan, Fergal Mc Caffery, Derek Flood, Fergal McCaffery

Experts in our system

1
Gilbert Regan
Dundalk IT
Total Publications: 17
 
2
Fergal Mc Caffery
University of Limerick
Total Publications: 121
 
3
Derek Flood
Dundalk IT
Total Publications: 30
 
4
Fergal McCaffery
Dundalk IT
Total Publications: 91