Traceability is an important component in developing quality software. In addition to regulatory requirements, organisations operating within the safety critical domain must employ an effective traceability process to ensure their software is safe. However, traceability implementation is problematic as most existing software systems lack explicit traceability links between artefacts. This problem has been highlighted in the medical device domain by an analysis of the traceability documents submitted to regulators in the United States as part of the medical device approval process.
This research is being led by Dr Gilbert Regan
The research of the RSRC focuses on the development and validation of a traceability assessment to assist medical device Small to Medium Enterprises (SMEs) to overcome the identified challenges. A framework called Traceability Assessment and Implementation Framework (TAIF) was developed from a PhD research at RSRC and The framework enables the assessment of a medical device SMEs current traceability status in addition to providing a pathway for improvement.