Meet our Subject Matter Experts

Christèle East, PhD

Senior Regulatory Consultant, IVD

Clinical, EU IVDR, FDA, IVD, Medical Writing, Quality, Regulatory

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Paul Steven, MS

Principal Biostatistician, IVD

Biostatistics, Clinical, EU IVDR, FDA, IVD, Quality, Regulatory

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Richard A. Vincins, BS, CMDA, CQA, RAC-Devices, M-TOPRA, CQP MCQI

Principal Strategy Consultant, Regulatory

EU IVDR, EU MDR, FDA, IVD, Medical Writing, Notified Body Expertise, Preclinical, Product Development, Quality, Regulatory, Validation

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Warren R. Jameson, PhD

Senior Manager, Regulatory & Quality

Clinical, EU IVDR, FDA, IVD, Medical Writing, Notified Body Expertise, Quality, Regulatory

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