园区淫乱

Meet our Subject Matter Experts

Jack Risdahl, DVM, PhD

Principal Strategy Consultant, Preclinical

FDA, Preclinical, Product Development

Jeff Geschwind, MD

Medical Director鈥揙ncology, Image-Guided Therapy, and Imaging Core Lab

Clinical, Director, FDA, Interventional & Surgical Research, Medical Writing, Preclinical, Regulatory

Marie-Eve Cluzel-Valentin

Principal Biological Safety and Validation Scientist

Biocompatibility, Biological Safety, Clinical, EU IVDR, FDA, IVD, Medical Writing, Microbiology, Regulatory, Validation

Meghan Hahn

Megan A. Hahn, PhD, DABT

Senior Toxicologist

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

Monica R. Monta帽ez, MS, RAC, CQA

Principal Strategy Consultant, Regulatory

FDA, Regulatory

Paul Steven, MS

Principal Biostatistician, IVD

Biostatistics, Clinical, EU IVDR, FDA, IVD, Quality, Regulatory

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

Richard Kotz, MS

Principal Strategy Consultant, Biostatistics

Biostatistics, Clinical, FDA, Product Development, Regulatory

Sarah B. Nelson, MS

Senior Strategy Consultant, Regulatory

EU IVDR, FDA, IVD, Product Development, Regulatory

Staci L. DeMoss, BS

Principal Validation Scientist

EU MDR, FDA, Quality, Regulatory, Validation

Steven Ullery, MS

Principal Strategy Consultant-Biostatistics

Biostatistics, Clinical, FDA

Sylvie Framery, PhD

Senior Principal Biological Safety Scientist

Biocompatibility, Biological Safety, FDA, Regulatory

Tim Petermann

Principal Chemist

Chemical Characterization, FDA

Tyson Rogers

Tyson Rogers, MS

Principal Strategy Consultant, Biostatistics

Biostatistics, Clinical, DSMB, FDA, Product Development

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