Meet our Subject Matter Experts

David Mandley, PhD

Principal Regulatory Consultant

EU MDR, Medical Writing, Notified Body Expertise, Preclinical, Product Development, Regulatory

Matt Royle, PhD

Principal Regulatory Consultant

EU MDR, Notified Body Expertise, Product Development, Quality, Regulatory

Pedro Eerdmans, MD, PhD

Director, Global Strategy Services

Clinical, Director, DSMB, EU MDR, FDA, Interventional & Surgical Research, Notified Body Expertise, Product Development, 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

Thomas Miramond, PhD, MSc, M-Eng.

Senior Regulatory Consultant

EU MDR, Notified Body Expertise, Preclinical, Product Development, Quality, Regulatory

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