Meet our Subject Matter Experts

Áine Mary Duffy, BSc (Hons), PhD

Clinical & Regulatory Operations Manager

Clinical, EU MDR, FDA, Medical Writing, Regulatory

Andy J. Wyen, MS, DABT, LAT

Principal Toxicologist

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, FDA, Toxicology

Angela Sanchez

Associate Scientific Director, Analytical Services

Chemical Characterization, EU MDR, FDA

Catherine Tremolieres, DVM

Manager, Biological Safety & Validation Consulting Services, Europe

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, FDA, Regulatory, Toxicology

Don Pohl, BS

Principal Strategy Consultant, Biocompatibility

Biocompatibility, Biological Safety, EU MDR, FDA, Regulatory

Gaëlle Clermont, PharmD, PhD

Principal Strategy Consultant

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

Meghan Hahn

Megan A. Hahn, PhD, DABT

Senior Toxicologist

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, FDA, Toxicology

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

Staci L. DeMoss, BS

Principal Validation Scientist

EU MDR, FDA, Quality, Regulatory, Validation

Valériane Levelut, PharmD, ERT, DABT

Senior Toxicologist

Biocompatibility, Biological Safety, EU MDR, FDA, Regulatory, Toxicology

Wendy Schroeder, BSN, CCRC/PM, CRCP

Principal Strategy Consultant, Clinical

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

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