园区淫乱

Meet our Subject Matter Experts

Jane Arnold-Round, MSc

Senior Principal Consultant, Regulatory

Clinical, EU MDR, Medical Writing, Notified Body Expertise, 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

Julie Nadeau

Senior Reimbursement Strategist

Regulatory, Reimbursement

Kevin Butcher

Principal Regulatory Consultant

EU MDR, Notified Body Expertise, Quality, Regulatory

Marie-Charlotte Notargiacomo

Senior Biological Safety Scientist

EU MDR, Medical Writing, Regulatory

Marie-Eve Cluzel-Valentin

Principal Biological Safety and Validation Scientist

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

Matt Royle, PhD

Principal Regulatory Consultant

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

Monica R. Monta帽ez, MS, RAC, CQA

Principal Strategy Consultant, Regulatory

FDA, Regulatory

Paul Risborough, B-Eng (HONS)

Principal Regulatory Consultant

Notified Body Expertise, 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

Rachel Gibbs, BSc, PhD

Principal Regulatory Consultant

Notified Body Expertise, 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

Sara Finocchietti, MEng, PhD

Senior Strategy Consultant, Clinical

Clinical, EU MDR, Product Development, Regulatory

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