"PhD Studentship in School of Computing: From Formal Requirements to Specification-based Automated Testing for Safety-Critical Medical Device Software Certification"

Newcastle University

Award Summary

100% fees covered, and a minimum tax-free annual living allowance of £20,780 (2025/26 UKRI rate). Additional project costs will also be provided.

Overview

Modern medical devices rely on software for safety-critical functions like life support, monitoring, and decision-making. They must comply with strict regulations (e.g., IEC 62304, ISO14971) that require trial-based safety assessments. Ensuring software safety, reliability, and regulatory approval is challenging, as failures often occur in rare or unforeseen situations, making traditional testing and trial-based approaches insufficient.

This PhD project explores how formal requirements and automated testing can produce clear, traceable, regulator-ready evidence for medical device software certification. Part of the international PlaTFoRm-project (Practical Testing of Formal Requirements), it involves UK and EU partners, including Newcastle University, D-RisQ Ltd, fortiss, and Verified International, and focuses on a safety-critical medical device software case study.

The project is particularly suitable for strong UK graduates interested in developing advanced research and technical skills while working on a problem with real societal impact, and motivated to improve workplace safety in healthcare technologies and to work across research, industry, and medical engineering.

Methodology

The overall aim of the project is to design and evaluate processes that integrate formal requirements and automated test generation based on formal specifications into medical device software development.

You will be trained to conduct research combining software engineering, formal methods, and safety assurance. Prior experience in formal methods or medical regulation is not required. The project includes training, supervision, and gradual progression into research work. The project will involve:

• Learning how to express software requirements precisely using formal models.
• Using these specifications to automatically generate test cases for software systems and code.
• Exploring how test results and verification evidence can be traced back to safety requirements.
• Assessing how this evidence supports medical device certification standards such as IEC62304 and ISO14971.

The project will deliver traceable workflows, formal requirement templates, and automatically generated verification artefacts for medical-device safety certification. It aims to promote industrial adoption and regulatory engagement, helping startups and SMEs overcome innovation bottlenecks and ultimately benefiting patients.

Timeline

Year 1: Analyse medical standards/processes; formalise requirements; prototype traceability. Expected outputs include requirement templates and an initial workshop paper.

Year 2: Integrate PlaTFoRm tools; evaluate coverage and fault robustness using the medical case study. Expected outputs include evaluation datasets and a journal submission.

Year 3: Assess workflow feasibility for certification; refine processes; disseminate through project partners. Expected outputs include thesis, publications and certification-related artefacts.

Supervision Environment

You will be based in Newcastle University’s Computing AMBER-group, focusing on safety-critical software, medical systems, simulation, and the Neuroprosthetics-group. A Master’s degree is helpful but not essential. You will collaborate with D-RisQ, Verified International, and fortiss on requirements, safety-critical test generation, static analysis, code testing, and system robustness testing. Opportunities include industrial engagement, international collaboration, and exposure to regulatory challenges, providing a strong foundation for careers in research, industry, or regulation.

Number Of Awards: 1

Start Date: 1 October 2026

Award Duration: 4 years

Application Closing Date: 15 February 2026

Sponsor: EPSRC

Supervisors: Dr Leo Freitas, Dr Ken Pierce, Prof. Patrick Degenaar

Eligibility & How to Apply

For eligibility criteria and how to apply please visit our website.

Contact Details

Leo Freitas or Kenneth Pierce