Meet our Subject Matter Experts

Christèle East, PhD

Christèle East, PhD

Senior Regulatory Consultant, IVD

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

Marie-Eve Cluzel-Valentin

Principal Biological Safety and Validation Scientist

Biocompatibility, Biological Safety, Clinical, EU IVDR, FDA, IVD, Medical Writing, Microbiology, Regulatory, Validation

Paul Steven, MS

Principal Biostatistician, IVD

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

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

Sarah B. Nelson, MS

Senior Strategy Consultant, Regulatory

EU IVDR, FDA, IVD, Product Development, Regulatory

Warren R. Jameson, PhD

Senior Manager, Regulatory & Quality

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

Wendy Schroeder, BSN, CCRC/PM, CRCP

Principal Strategy Consultant, Clinical

Clinical, EU IVDR, EU MDR, FDA, IVD, Regulatory

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