Traceability Roadmap

Pattern Attributes

Intervention Process
Domain Medical
Work Programme SPRTMDRC
Research Area Any
Evidence Type Survey, Lit. review
Evidence Source Multi-nationals, SMEs, literature;
Evidence Strength Very strong
Trigger product_domain == medical, lifecycle_phase > 0


Traceability of requirements through the software development lifecycle 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 plays an important role in defect management, change management and project management and global software development It is fundamental for change impact analysis, requirements validation and regression testing among others. In the safety critical domain traceability is essential to producing safe software. Numerous reasons have been identified for reluctance in implementing traceability including the fact that while the medical device standards state what traceability should be in place, there are no guidelines stating how to implement traceability. This often leads to organisations employing ineffective traceability processes


Provide a roadmap which will guide organisations in implementing effective traceability. The roadmap will consist of goals (which are the traceability requirements taken directly from the medical device standards and guidelines), database of activities indicating how to achieve each goal.


  1. Regan, G., Mc Caffery, F., McDaid, K., Flood, D. (2013) Implementation of Traceability Best Practices within the Medical Device Domain. In:European Systems and Software Process Improvement and Innovation Conference, EuroSPI/ Dundalk, Ireland

  2. Regan, G., Mc Caffery, F., McDaid, K., Flood, D. (2013) Medical Device Standards’ Requirements for Traceability during the Software Development Lifecycle and Implementation of a Traceability Assessment Model. In: Journal of Computer Standards & Interfaces

  3. Flood, D., Mc Caffery, F., Casey, V., Regan, G.,(2013) “A Methodology for Software Process Improvement Roadmaps for Regulated Domains - Example with ISO 62366”, European System, Software & Service Process Improvement & Innovation (EuroSPI 2013)