Abstract. Developing safety critical software is a complex process. Due to the fact that medical device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in the medical device domain. Risk management has an important role in medical device software development as it is important to ensure that safe software is developed. Demonstrating traceability of requirements right throughout the medical device software development and maintenance lifecycles is an important part of demonstrating that 'safe' software has been produced through adopting defined processes. Consequently, medical device standards and guidelines emphasise the need for traceability. This paper outlines the extent and diversity of traceability requirements within medical device standards and guidelines, and identifies the requirements for traceability through each phase of the software development lifecycle. The paper also summarises the findings obtained when a lightweight assessment method (MedTrace), that we created, based upon the traceability practices within these standards, was implemented in two SME organisations. Finally we highlight how the findings indicate a lack of guidance as to what is required when implementing and maintaining a traceability process.

Abstract. 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.

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