We are one of seven Centres of Excellence for Regulatory Science and Innovation (CERSIs) who have been awarded government funding through UK Research and Innovation (UKRI) funding agency and the Medicines and Healthcare products Regulatory Agency (MHRA).
ABOUT US
The CERSI IVD network focuses on assisting the efficient and safe availability of medical diagnostic tests in the UK, by building a collaborative network of regulators, industry, people living with disease and users of tests and researchers.
Efficient regulation of diagnostic tests not only assists patient and consumer safety, but also improves the nation's health, the NHS workload, industry, regulators overseeing test approvals, as well as making the UK attractive for business leadership in regulation and research.
WHAT WE DO
Clinical Evidence
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Good practice for IVD regulatory document development - Standards for clinical evidence for IVDs
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To increase clarity on “state of the art” method to support and guide stakeholders
Post Market Surveillance
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Good practice for Post Market Surveillance (PMS)
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To review and develop methods and examples to guide PMS study design to support stakeholders
Network
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Establishment of a dynamic, collaborative virtual network for regulatory science
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To develop a global IVD Regulatory Science Network and Knowledge Exchange Forum
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Stakeholder engagement and involvement including regulators, standards organisations, industry experts, consultancy companies, approved/notified bodies, academic researchers, patients and end-users
PROJECT UPDATES
Come back regularly to see our project updates over the next few months. We will be looking for stakeholder engagement and you will be able to see how you can get involved.
OUR PARTNERS
