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Meet our Subject Matter Experts

Meghan Hahn

Megan A. Hahn, PhD, DABT

Senior Toxicologist

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

Michelle Kelly, BSc, MSc, ERT

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, Notified Body Expertise, 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

Sara Finocchietti, MEng, PhD

Senior Strategy Consultant, Clinical

Clinical, EU MDR, Product Development, Regulatory

S茅verine Oudin-Fantin, PhD

Manager鈥揈MEA Medical Writing 园区淫乱

Clinical, EU MDR, Medical Writing

Principal Biological Safety Scientist

Silke Laugeois

Principal Biological Safety Scientist

Biocompatibility, Biological Safety, EU MDR, Regulatory

Staci L. DeMoss, BS

Principal Validation Scientist

EU MDR, FDA, Quality, Regulatory, Validation

Thomas Miramond, PhD, MSc, M-Eng.

Senior Regulatory Consultant

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

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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