A Traceability Process Assessment Model for the Medical Device Domain

Regan, Gilbert and Biro, Miklos and McCaffery, Fergal and McDaid, Kevin and Flood, Derek (2014) A Traceability Process Assessment Model for the Medical Device Domain. In: EuroSPI 2014, 25-27 June, Luxembourg.

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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 devel-opment 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.

Item Type: Conference or Workshop Item (Paper)
Uncontrolled Keywords: Software deveopment; Medical devices; Traceability process assessment model.
Subjects: Computer Science
Research Centres: Regulated Software Research Centre
Depositing User: Gilbert Regan
Date Deposited: 11 Dec 2014 12:41
Last Modified: 20 May 2016 11:21
License: Creative Commons: Attribution-Noncommercial-Share Alike 4.0

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