Implementation of traceability best practices within the medical device domain.

Requirements validation, compliance verification and impact analysis are important activities that are performed during the software development lifecycle. Traceability of requirements through the software development lifecycle (SDLC) is essential in the development of safety critical software. Organisations such as the Food and Drug Administration and the Federal Aviation Authority in the United States require traceability as part of their approval process. However, despite its criticality there is extensive digression in the practices and usefulness of traceability across development projects. Many projects’ traceability efforts are simply focused on satisfying regulations and do not leverage the many benefits of traceability. Traceability, if fully implemented is an important tool for managing system development and there are a number of published best practices to help companies with this implementation. By means of a literature review we record a list of the commonly accepted best practices for traceability implementation. Furthermore, through interviews with two medical device companies we report that a number of these practices are unfamiliar to these companies and why an even greater number of these practices are not applied