PhD studentship in Computer Science: From Formal Requirements to Specification-based Automated Testing for Safety-Critical Medical Device Software Certification

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 heavily on software to deliver safety-critical functionality, including supporting life-sustaining functions, automated monitoring, and clinical decision-making. Such systems must meet strict regulatory requirements (e.g., IEC 62304 [1] and ISO14971 [2]), which demand a trial-based approach to safety. Ensuring that this software is safe, reliable, and acceptable to regulators is essential, yet remains a major challenge for industry. Many software-related failures only appear in rare or unexpected situations, meaning that traditional testing and trial-based approaches are often insufficient.

This PhD project will explore how formal (mathematical) requirements and automated testing techniques can be used to produce clear, traceable, and regulator-ready evidence for medical device software certification. The research is part of the international PlaTFoRm project (Practical Testing of Formal Requirements) [6] which tackles these issues through collaboration between UK and EU partners, including Newcastle University and D-RisQ Ltd in the UK, and Fortiss and Verified International in Germany, and focuses on a real safety-critical medical device software case study.

The project is particularly suitable for strong UK graduates who are interested in developing advanced research and technical skills while working on a problem with real societal impact and who are motivated to improve workplace safety in healthcare technologies and 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 formal specification-based automated test-generation into medical device software development processes.

You will be trained to carry out research that combines software engineering, formal methods, and safety assurance. You are not expected to have prior experience in formal methods or medical regulation. Training, supervision, and gradual progression into research-level work are integral parts of the project. 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 IEC 62304 and ISO 14971.

The project will deliver traceable workflows, formal requirement templates and automatically generated verification artefacts suitable for use in medical-device safety certification. It aims to contribute to industrial adoption and regulatory engagement. This will address the innovation bottleneck faced by medical device startups/SMEs, and ultimately benefit 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 (Advanced Model-Based Engineering and Reasoning), focusing on safety-critical software engineering, medical systems, and simulation, as well as the EEE Neuroprosthetics group. Having a Master’s degree is helpful but not essential. You will collaborate with D-RisQ Ltd (UK) on formal requirements and safety-critical test generation, Verified International (Germany) on static analysis and code testing, and fortiss (Germany) on search-based system-level robustness testing. Opportunities include industrial engagement, international collaboration, and exposure to real regulatory challenges, making this an excellent foundation for careers in research, industry, or regulation.

[1] IEC 62304 . Medical device software life cycle processes.

[2] ISO 14971 . Medical Devices – Application of Risk management to medical devices.

[3] Formal techniques in the safety analysis of software components of a new dialysis machine , Science of Computer Programming, Volume-175, 2019, p17-34 

[4] MC/DC . Modified Condition/Decision Coverage criterion.

[5] FDA General Principles of Software Validation for Medical devices .

[6] PlaTFoRm Project, https://www.fortiss.org/en/research/projects/detail/platform .

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 Criteria

We are adopting a contextual admissions process. This means we will consider other key competencies and experience alongside your academic qualifications. An example can be found here .

A minimum 2:1 Honours degree or international equivalent in a subject relevant to the proposed PhD project is our standard entry, however we place value on prior experience, enthusiasm for research, and the ability to think and work independently. Excellent Analytical skills and strong verbal and written communication skills are also essential requirements. A Masters qualification may not be required if you have a minimum 2:1 degree or can evidence alternative experience in a work or research-based project. If you have alternative qualifications or experience, please contact us to discuss flexibilities and request an exemption.

Applicants whose first language is not English require an IELTS score of 6.5 overall with a minimum of 5.5 in all sub-skills. International applicants may require an ATAS (Academic Technology Approval Scheme ) clearance certificate prior to obtaining their visa and to study on this programme. 

How To Apply

How to apply

Please read and complete this document as your Personal statement, and upload this with your application. Applications which do not include this document will not be considered. Further details can be found here .

You must apply through the University’s Apply to Newcastle Portal  

Once registered select ‘Create a Postgraduate Application’.  

Use ‘Course Search’ to identify your programme of study:  

·       search for the ‘Course Title’ using the programme code: 8050F

·       select PhD Computer Science (full time) as the programme of study

You will then need to provide the following information in the ‘Further Details’ section:  

·       a ‘Personal Statement’ (this is a mandatory field) – Use this template.

·       the studentship code DLA2633 in the ‘Studentship/Partnership Reference’ field.  

·       when prompted for how you are providing your research proposal - select ‘Write Proposal’. You should then type in the title of the research project from this advert. You do not need to upload a research proposal.  

You must submit one application per studentship; you cannot apply for multiple studentships on one application.

Contact Details

Leo Freitas or Kenneth Pierce