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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.
KeywordsMedical Device Software Traceability Software Process Improvement SPI Lightweight Assessment Method SPICE CMMI®
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