Med-Trace: Traceability Assessment Method for Medical Device Software Development

Casey, Valentine and McCaffery, Fergal (2011) Med-Trace: Traceability Assessment Method for Medical Device Software Development. In: European Systems and Software Process Improvement and Innovation Conference, EuroSPI 2011, 27th - 29th June 2011, Roskilde University, Denmark.

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Abstract

Traceability is central to medical device software development and is an essential requirement for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This process must ensure the need for clear linkages and traceability from software requirements - including risks - through the different stages of the software development and maintenance lifecycles. This is difficult to achieve due to the lack of specific guidance which the medical device standards and documentation provide. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper we outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry. We also present and discuss our findings from two industry based Med-Trace assessments.

Item Type:	Conference or Workshop Item (Paper)
Uncontrolled Keywords:	Medical Device Standards; Medical Device Software Traceability; Medical Device Software Process Assessment and Improvement; Risk Management; Assessment Method
Subjects:	Computer Science
Research Centres:	UNSPECIFIED
Depositing User:	Nicola Hanlon
Date Deposited:	16 Aug 2011 08:36
Last Modified:	11 Nov 2014 16:10
URI:	https://eprints.dkit.ie/id/eprint/52

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