Meet our Subject Matter Experts

Áine Mary Duffy, BSc (Hons), PhD

Clinical & Regulatory Operations Manager

Clinical, EU MDR, FDA, Medical Writing, Regulatory

Christèle East, PhD

Christèle East, PhD

Senior Regulatory Consultant, IVD

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

Gaëlle Clermont, PharmD, PhD

Principal Strategy Consultant

Biological Safety, EU MDR, FDA, Medical Writing, Preclinical, Product Development, Regulatory

Jeff Geschwind, MD

Medical Director–Oncology, Image-Guided Therapy, and Imaging Core Lab

Clinical, Director, FDA, Interventional & Surgical Research, Medical Writing, Preclinical, Regulatory

Marie-Eve Cluzel-Valentin

Principal Biological Safety and Validation Scientist

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

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

Warren R. Jameson, PhD

Senior Manager, Regulatory & Quality

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

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