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OUR MISSION

We are advancing regulatory science to enable safe, effective, and equitable diagnostic innovation. CLEARED CERSI IVD connects regulators, researchers, clinicians, industry, and people living with disease to improve how evidence for In-Vitro Diagnostic (IVD) technologies including AI and digital diagnostics is developed, evaluated, and shared.

Through our three core goals, we:

Develop good practice in regulatory documentation to support high-quality, evidence-based test design.

Advance post-market surveillance methods to ensure ongoing safety, reliability, and fairness of diagnostics in use.

Build a collaborative virtual network that drives learning, engagement, and innovation across the regulatory science community.

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Together, we’re creating a trusted foundation for faster, more transparent, and globally aligned regulation of diagnostic technologies.

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© 2026 by CERSI IVD. All rights reserved.

CERSI-IVD: Centre of Excellence for Regulatory Science and Innovation (CERSIs) of In Vitro Diagnostic (IVD) tests. Clinical Evaluation and Assessment for Regulation of In Vitro Diagnostic tests (CLEARED IVD).

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