Meet our Subject Matter Experts

Marie-Charlotte Notargiacomo

Senior Biological Safety Scientist

Biocompatibility, Biological Safety, 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

Michael A. Jorgenson, BS

Principal Interventionalist

Interventional & Surgical Research, Preclinical

Michelle Kelly, BSc, MSc, ERT

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

Monica R. Montañez, MS, RAC, CQA

Principal Strategy Consultant, Regulatory

FDA, Regulatory

Mukarram Mohiuddin, MPH

Mukarram Mohiuddin

Clinical Database Developer, IVD

Biostatistics, IVD

Pedro Eerdmans, MD, PhD

Director, Global Strategy Services

Clinical, Director, DSMB, EU MDR, FDA, Interventional & Surgical Research, Notified Body Expertise, Product Development, Regulatory

Peter Shores

Principal Biostatistician

Phillip Smiraldo, PhD, DABT

Principal Toxicologist

Biocompatibility, Biological Safety, Preclinical, Toxicology

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

Sandi Schaible

Executive Director, Analytical Chemistry and Regulatory Toxicology

Biocompatibility, Biological Safety, Chemical Characterization, FDA, Preclinical, Regulatory

Sara Finocchietti, MEng, PhD

Senior Strategy Consultant, Clinical

Clinical, EU MDR, Product Development, Regulatory

Sarah B. Nelson, MS

Senior Strategy Consultant, Regulatory

EU IVDR, FDA, IVD, Product Development, Regulatory

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