PARTNERS
INSTITUTIONAL PARTNERS
UCL brings world-class expertise in diagnostic imaging, clinical evaluation, and biostatistics to CLEARED CERSI IVD.
Led by Professor Sue Mallett, with Dr Caroline Moore, Dr Shonit Punwani, and Dr Steve Halligan, the UCL team strengthens evidence generation and post-market methodologies that underpin robust, science-led regulation of diagnostics.
The University of Leeds and Leeds Teaching Hospitals NHS Trust provide nationally recognised leadership in infection diagnostics, regulatory science, and health technology innovation.
Led by Professor Mark Wilcox, Dr Kerrie Davies, Dr Jane Freeman, and Dr Paola Cocco, the team supports CLEARED CERSI IVD’s mission to enhance real-world evidence and ensure diagnostic innovations deliver safe, effective, and equitable patient care.
INDUSTRY PARTNERS
Psephos Limited
Psephos Limited are regulatory and clinical consultants specialising in medical device and IVD compliance with over 30 years’ experience working within UK Health infrastructure, including as a UK Responsible Person. Psephos provide and disseminate summaries of changes to UK medical device regulations, including those relevant to this network.
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Led by Robin Stephens and Irfan Hassan and supported by Jane Hargreaves and Jane Medina Haines, the team will be co-ordinating the communication and networking aspects of the project.
Insightful Health
Insightful Health is a UK specialised technical and regulatory consultancy focused on guiding in vitro diagnostic (IVD) manufacturers through regulatory and reimbursement pathways and improving access to diagnostics.
Led by Mike Messenger who will be working alongside Robyn Meurant, supporting clinical evidence generation and providing regulatory guidance for diagnostics.
ACT IVD
ACT-IVD is a French regulatory consultancy firm advising a range of international Regulatory Authorities, Donors/Charities, UN Organisations, Non-Government-Organisations and Industry on their regulatory and market access strategies.
Led by Robyn Meurant, who will be supporting clinical evidence generation and provision of regulatory guidance for diagnostics, alongside Mike Messenger.
OTHER PARTNERS
British In Vitro Diagnostics Association (BIVDA)
The British In Vitro Diagnostics Association (BIVDA), the UK’s leading trade association representing the IVD industry, is a key supporter of the CLEARED CERSI IVD Network. Representing companies from global organisations to innovative SMEs, BIVDA advocates for an evidence-based regulatory environment that supports safe, effective, and equitable diagnostic innovation.
Through its collaboration with CLEARED CERSI & BIVDA this partnership strengthens regulatory preparedness, fosters innovation, and advances the UK’s position as a global leader in diagnostic science and policy.