The DigitalHealth.London RADIANT-CERSI Innovator Support programme is designed to improve understanding of the regulatory landscape and compliance process for Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD). Its key goal is to support valuable UK medical innovations to reach the market safely and efficiently.
Partnering with RADIANT-CERSI
RADIANT-CERSI is one of seven Centre of Excellence in Regulatory Science and Innovation (CERSI) in Transformative Digital Health and AI across the UK. It is funded by Innovate UK, in partnership with the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Office for Life Sciences (OLS).
It is led by Brunel University of London, with partners across healthcare, research and academia, including the Health Innovation Network South London, Helix Data Innovation, Zinc, UCL, Imperial College Healthcare NHS Trust, King’s College London and BMJ.
DigitalHealth.London forms part of RADIANT-CERSI’s advisory board, alongside Osborne Clarke, University of Cambridge, NIHR HealthTech Research Centre, Department for Business and Trade, Association of British HealthTech Industries (ABHI), NIHR Applied Research Collaborative, GSK and National Institute for Health and Care Excellence (NICE).
RADIANT-CERSI is on a mission to bridge the gap between regulatory science and real-world innovation. By streamlining access to timely regulation, the network aims to foster a business-friendly, evidence-based and sustainable regulatory environment. This will support the safe and efficient development of AI and digital health technologies, shaping the future of healthcare and enabling continued growth in the sector.
Supporting start-ups to navigate regulation
The programme was delivered between May 2025 and November 2025. As part of RADIANT-CERSI, the Health Innovation Network South London and DigitalHealth.London delivered an online innovator support programme this summer. This series of nine online workshops supported 65 digital health companies in navigating current regulatory requirements for Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD), with topics including regulatory frameworks, clinical evaluation, and quality management.
What’s involved?
- Understand regulation practicalities
Sessions from regulatory bodies helped improve understanding on how to navigate current regulatory requirements for SaMD and AIaMD.
- Identify regulation roadmap
Subject matters experts provided knowledge and guidance on how to direct the development and evaluation of digital health solutions.
- Curated Resources
Resource offered information and practical advice on how to plan regulatory compliance activities.
- Knowledge exchange with experts and peers
Providing a forum for identifying challenges and risks associated with the development of AI in healthcare and facilitating opportunities to hear from peers, experts and stakeholders.
- Connected with RADIANT-CERSI
Ongoing network provided regulatory guidance, enabling access to additional resources and networking opportunities within the broader RADIANT-CERSI network.
Who was the programme for?
Supporting start-ups to navigate regulation
The DigitalHealth.London RADIANT-CERSI Innovator Support programme was open to companies that meet the following criteria:
- UK-registered start-up.
- The company’s technology must be a software as a medical device (SaMD) or an artificial intelligence as a medical device (AIaMD).
- The technology can be of any class (I, IIa, IIb, III) but must have a technology readiness level of 4 or above.
- The online programme was delivered between w/c 16 June and w/c 8 September. Applicants were required to be available during this period to attend nine virtual workshops, each of which would be up to 2.5 hours in length. As this was a high-value, fully funded opportunity, full attendance of the online programme was expected.
What was required by companies as part of the programme?
- Attend weekly webinars starting w/c 16th June (webinars will be up to 2.5 hours and a full schedule will be provided upon acceptance to the online programme).
- Attend the online programme in full, as this is a high-value, fully funded opportunity.
- Provide evidence to support online programme metrics.
- Provide feedback throughout the online programme.
- Provide information about your company and your understanding of the regulatory compliance process as part of the onboarding process, and at the end of the online programme.
Outcomes of the programme
Participants left with more than just enhanced regulatory knowledge; they gained structured pathways for progressing regulatory activities and greater confidence in navigating complex requirements. The collaborative nature of the programme also fostered lasting peer connections, creating a network for continued shared learning.
Noteworthy outcomes:
- Great NPS:
Net promoter category
- 100% of participants*
Agreed the programme was appropriate for their stage of the regulatory journey
- 86% of participants*
Said they have or will change their approach to regulatory compliance as a result of the programme
*of participants surveyed
The session [on quality management systems] opened our eyes to QMS approach for compliance. We know how expensive and timely it is to find a QMS. The advice was HUGE in terms of value, and we have utilised this and started to implement it, which will help us in so many different aspects of our medical device journey.”
Particpant
“Today’s session was quite revealing, there is a limit to how much the regulatory consultants can tell us. But actual businesses or organisaitons going through the process shows us how it’s done from a first-person perspective.”
Particpant
Spotlight on the RADIANT-CERSI DigitalHealth.London Innovator Support programme
We got to hear from first cohort of the programme, MedForce AI, Omnilabs Research and Suna Health share how the knowledge gained has gone on to shape value propositions, professional growth and business development.
Case studies of the programme’s impact on these companies can be found below.
MedForce AI
MedForce AI develops specialist diagnostic GenAI products designed to reduce waiting lists and prevent adverse events.
Jay Liu, CEO and founder of MedForce AI, shares how the programme boosted their confidence and deepened their knowledge of regulatory pathways.
Omnilabs Research
Omnihuman VR is a personalised telerehabilitation tool designed to support stroke survivors by improving adherence to exercises.
Lucie Legrandois, Co-founder of Omnilabs Research, shares how the programme provided valuable access to a network of peers and professionals, with expert-led sessions, practical insights and tools that helped kick-start their regulatory journey.
Suna Health
Suna Health’s wearable patch uses AI-powered acoustic detection to continuously monitor gastrointestinal activity.
Dr Chad Okay, Founder of Suna Health and NHS GP resident, shares how the programme transformed regulation from a “black box” into a strategic process, helping the company to plan for future growth.
Find out more
Learn more about the programme’s design and how key learnings from the programme will shape the future of regulation.
Latest opportunities from RADIANT-CERSI
Applications are now closed for the DigitalHealth.London RADIANT-CERSI Innovator Support Programme. Click the button below to find out more about the latest opportunities from RADIANT-CERSI.