Impact of standards on the role and application of traceability in the medical device domain

Abstract

Software failure in the medical device domain can lead to injury or death. Controlling this risk is fundamental to producing quality software. To produce quality software, an effective requirements and hazards traceability process is required. Hence traceability is central to medical device software de-velopment. It is also an essential requirement for regulatory approval. The ne-cessity for traceability is reinforced by the medical device standards and guide-lines. In this paper we outline how traceability is an important part of medical device software development, what standards contain reference to traceability, and which specific clauses within those standards companies should refer to when defining their traceability processes. We also summarise the findings ob-tained when a lightweight assessment method (Med-Trace), that we created, based upon the traceability practices within these standards, was implemented in two SME organizations.