Regulatory Journey Support Projects
At RADIANT-CERSI, we know that the path to regulatory approval in digital health and AI is complex, yet a key step for innovators looking to safely deploy impactful solutions.
That is why we launched the Regulatory Journey Support Projects (RJSP): a funding and collaboration opportunity for individuals and organisations navigating regulatory challenges in Software as a Medical Device (SaMD), AI as a Medical Device (AIaMD), and wider areas including data governance and AI regulation.
In August 2025, we awarded six projects up to £10,000 each to explore regulatory pain points, develop practical tools, and share their findings with the wider health innovation community.
We received a high number of excellent applications and want to thank all those who applied. The selected projects stood out for their clarity, relevance, and potential to generate insight for others.
Meet the 2025 RJSP Awardees
We selected three projects under Route A (teams on a regulatory journey) and three under Route B (projects supporting others on that journey). For more details on the two routes, please visit our Regulatory Journey Support Projects Application page.
All six awardees will receive tailored support from RADIANT-CERSI between now and December 2025, including mentorship, access to our expert network, and opportunities to contribute to regulatory science research.
Route A: Innovators Navigating Regulation
Route B: Projects Supporting the Ecosystem
This project is led by Affiniti AI, a UK-based digital health start-up developing regulated AI tools for blended mental health therapy; in collaboration with 8foldGovernance, regulatory affairs specialists with deep expertise in medical device compliance. This project outlines Affiniti’s roadmap and regulatory strategy for upgrading its classification, unlocking greater economic and clinical value for healthcare providers and patients alike.
apo is a UK-based digital health startup developing an AI-enabled SaMD for musculoskeletal self-management. They propose to build and test PMS Copilot, an AI-powered assistant designed to help early-stage digital health and AI companies implement meaningful post-market surveillance (PMS) practices aligned with UKCA requirements.
Aival is a startup developing an independent quality assurance platform for AI in healthcare. It provides hospitals with software for evaluating and monitoring AI. They propose a systematic study of the outputs of a post-deployment surveillance system to monitor a chest x-ray AI product, using an existing deployment at an NHS Trust.
Guy’s and St Thomas’ NHS Foundation Trust department of Clinical Scientific Computing. This project will be a partnership with the non-profit organisation Sense about Science, led by Director Tracey Brown OBE. Their vision is to deliver a free, open-source Quality Management System (QMS) tailored for Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD).
Curistica is a healthtech consultancy specialising in compliance and safety work for both manufacturers and buyers of Digital Health Technologies (DHTs). They propose an AI-powered compliance co-pilot specifically designed for health tech. This solution enhances Clinical Safety Officer (CSO) capacity while elevating output quality, particularly for less experienced officers.
IngeniumAI is a spin-out company from the University of Bath and the Royal United Hospitals NHS Trust (RUH), Bath. They propose to determine which of the many different AI explainability techniques, safeguards, and supporting methods for safe deployment of medical imaging AI described in academic literature are the most informative for a range of stakeholders.
What’s Next?
We’ll be working closely with all six teams over the coming months to maximise their impact. Each will publish a public report on their project by the end of 2025, contributing valuable learning to the RADIANT-CERSI community and the wider UK health innovation ecosystem.
If you have any questions or would like to discuss anything in particular, feel free to reach out to us at info@radiant-cersi.org. You can also join our community of innovators and experts on Slack.