A Traceability Process Assessment Model for the Medical Device Domain

Traceability of requirements through the software development lifecycle (including supporting processes such as risk management and change management) is a difficult and expensive task. The implementation of effective traceability allows organizations to leverage its many advantages, such as impact analysis, product verification and validation, and facilitation of code maintenance. Traceability is conducive to producing quality software. Within the medical device domain, as in other safety critical domains, software must provide reliability, safety and security because failure to do so can lead to injury or death. However, despite its criticality most software systems don’t employ explicit traceability between artefacts. Numerous barriers hamper the effective implementation of traceability such as cost, complexity of relationship between artefacts, calculating a return on investment, different stakeholder viewpoints, lack of awareness of traceability and a lack of guidance as to how to implement traceability. To assist medical device organisations in addressing the lack of guidance on how to implement effective traceability, this paper aims to present the development of a traceability process assessment model and how traceability process assessment and maintenance could be fully automated using the Open Services for Lifecycle Collaboration (OSLC) initiative. The process assessment model will allow organisations to identify strengths and weaknesses in their existing traceability process and pinpoint areas for improvement.