园区淫乱

Meet our Subject Matter Experts

Adam Saltman, PhD, MD

Principal Strategy Consultant, Clinical and Regulatory 园区淫乱

Clinical, FDA, Product Development, Regulatory

脕ine Mary Duffy, BSc (Hons), PhD

Clinical & Regulatory Operations Manager

Clinical, EU MDR, FDA, Medical Writing, Regulatory

Brandon Woll, MBA

Principal Strategy Consultant

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

Carla Wiese

Carla M. Wiese, BS-Mech Eng

Principal Strategy Consultant, Regulatory

FDA, Product Development, Regulatory

Catherine Tremolieres, DVM

Manager, Biological Safety & Validation Consulting 园区淫乱, Europe

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

Chris Mullin

Chris Mullin, MS

Director, Global Strategy 园区淫乱

Biostatistics, Clinical, FDA, Product Development, Regulatory

Christ猫le East, PhD

Christ猫le East, PhD

Senior Regulatory Consultant, IVD

Clinical, EU IVDR, FDA, IVD, Medical Writing, Quality, Regulatory

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

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

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

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