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Med-Trace: traceability assessment method for medical device software development
Casey, Valentine; Mc Caffery, Fergal
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.
Keyword(s): medical device standards; medical device software
Publication Date:
2011
Type: Conference item
Peer-Reviewed: Yes
Language(s): English
Institution: University of Limerick
Funder(s): Science Foundation Ireland
Citation(s): European Systems and Software Process Imporvement and Innovation Conference EuroSP1;2011
07/SKI1299
08/IN.1I2030
03/CE2I303_1
First Indexed: 2011-12-23 05:27:50 Last Updated: 2019-09-19 06:28:28