Journal Article


Gilbert Regan
Derek Flood
Fergal McCaffery


Computer Science

roadmap medical device non compliance validation computer software traceability requirements traceability safety critical

The Development and Validation of a Roadmap for Traceability. (2015)

Abstract Organisations who operate in the safety critical domains such as the medical device, avaition, and automotive domains must ensure their software is safe and provide objective evidence to this effect. One way of achieving this is by adhering to domain specific regulations and guidelines which specify a comprehensive implementation of traceability. However there is a gap between regulatory traceability requirements and what is implemented in practice. This lack of compliance means that organisations find it difficult to assess the safety of their software and thus ensure its safety. One reason for non-compliance with regards to traceability is a lack of guidance on what traceability to implement or how to implement it. In this paper we present the development and validation of a roadmap for the implementation of traceability in the medical device domain. The roadmap will provide medical device organisations with a pathway for effective traceability implementation.
Collections Ireland -> Dundalk IT -> Subject = Computer Science: Computer Software
Ireland -> Dundalk IT -> Status = Published
Ireland -> Dundalk IT -> Type = Article

Full list of authors on original publication

Gilbert Regan, Derek Flood, Fergal McCaffery

Experts in our system

Gilbert Regan
Dundalk IT
Total Publications: 17
Derek Flood
Dundalk IT
Total Publications: 30
Fergal McCaffery
Dundalk IT
Total Publications: 91