McCaffery, Fergal and Casey, Valentine (2011) Med-Trace. In: 11th International SPICE Conference on Process Improvement and Capability Determination 2011, 30th May to 1st June 2011, Dublin City University, Ireland.

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Traceability is central to medical device software development and essential for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This is difficult to achieve due to the lack of specific guidance which the medical device regulations and standards provides. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper we briefly outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry.

Item Type: Conference or Workshop Item (Paper)
Uncontrolled Keywords: Medical Device Software Traceability; Software Process Improvement; SPI; Lightweight Assessment Method; SPICE, CMMI
Subjects: Computer Science
Research Centres: Regulated Software Research Centre
Depositing User: Nicola Hanlon
Date Deposited: 16 Aug 2011 08:38
Last Modified: 11 Nov 2014 16:10

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