REgulatory SCience INNOVATOR SUPPORT PROGRAMME 2025-2026
To support further the 69 companies who have taken part in the RADIANT-CERSI / Digital Health.London Innovator Support Programme, as well as those who were unable to enrol, we are making most of the resources available to enhance access. We welcome your feedback on these resources and suggestions for additional topics you would find useful. Please get in touch with us at INFO@RADIANT-CERSI.ORG
Webinars
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Introduction to Software / AI as a Medical Device
Delivered by 8Fold Governance
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Technical File – Clinical Evaluation
Clinical Evaluation of Medical Devices delivered by Blum Health (https://blumtechgroup.com/)
Introduction to SPIRIT-AI and CONSORT-AI by Dr Tahmina Zebin, Brunel University of London (brunel.ac.uk)
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Quality Management and Post-market Surveillance
QMS delivered by the Clinical Scientific Computing team at Guys and St Thomas NHS Foundation Trust (https://gstt-csc.github.io/)
PMS delivered by 8Fold Governance
(https://8foldgovernance.com)
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Data Protection and Information security
Delivered by Guys and St Thomas NHS Foundation Trust (https://www.guysandstthomas.nhs.uk/)
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NHS regulation of digital tech and Apps, AI Framework
(DTAC, DCB0129, DCB0160)
Delivered by Assuric (https://www.assuric.com/)
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International standards and regulatory frameworks
Delivered by 8Fold Governance (https://8foldgovernance.com/)
Case Studies
See the real-world impact of the programme through the stories of other innovators
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MedForce AI
“The programme has provided certainty, which cannot be underestimated when planning timelines, revenues and resources. This is especially relevant when talking to investors.”
Jay Liu, Co-founder and CEO at MedForceAI
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Omnilabs research
“This programme was perfect to push us to kick off our regulatory journey. We developed a long-term roadmap, started our QMS and clinical trial design according to best standards and regulations,”
Lucie Legrandois, Co-founder at Omnilabs Research
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Suna Health
“The programme transformed regulation from an impenetrable black box into a structured process…It gave me clarity on how intended use statements drive classification decisions and introduced open-source QMS tools”
Dr Chad Okay, Founder and CEO of Suna Health
