Meet our Subject Matter Experts

Brandon Woll, MBA

Principal Strategy Consultant

Director, FDA, Preclinical, Product Development, Quality, Regulatory, Validation

David Mandley, PhD

Principal Regulatory Consultant

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

Gaëlle Clermont, PharmD, PhD

Principal Strategy Consultant

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

Jack Risdahl, DVM, PhD

Principal Strategy Consultant, Preclinical

FDA, Preclinical, Product Development

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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