园区淫乱

Meet our Subject Matter Experts

脕ine 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 园区淫乱

Chemical Characterization, EU MDR, FDA

Catherine Tremolieres, DVM

Manager, Biological Safety & Validation Consulting 园区淫乱, 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

Ga毛lle 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 园区淫乱

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

Val茅riane 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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