Meet our Subject Matter Experts

Adam E. Saltman, MD, PhD

Chief Medical Officer

Cardiology, Software, US FDA, Worked for US FDA

Adam Kopel

Assistant Interventionalist

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Adrian Keene

Associate VP, Global Biological Safety & Validation and EMEA Consulting Services

Biological Safety, EU IVDR/MDR

Áine Mary Duffy, BSc (Hons), PhD

Associate Director, Clinical Strategy

EU IVDR/MDR, Medical Writing, US FDA

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Alexander Hermann, PhD

Supervisor, Study Director Group

Biological Safety, Chemical Characterization, US FDA

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Alfred Dibao-Dina, PhD, DABT, ERT

Biological Safety Scientist

Biocompatibility, Biological Safety

Andrea Perciaccante

Analysis Leader

Market Research

Andy J. Wyen, MS, DABT, LAT

Principal Toxicologist

Biocompatibility, Biological Safety, Chemical Characterization, EU IVDR/MDR, Toxicology, US FDA

Angela Sanchez

Associate Scientific Director, Analytical Services

Cardiology, Chemical Characterization, EU IVDR/MDR, Orthopedics, US FDA, Wound Care

Ariadna Navarro, PhD

Senior Strategy Consultant

EU IVDR/MDR, In Vitro Diagnostics, Medical Writing

Aurélie San Juan, MSc, PhD

Principal Medical Writer, Regulatory

EU IVDR/MDR, Medical Writing, Orthopedics, Wound Care

Barb Mercier

Manager, Clinical Research Associates

Data Management, Trial Management

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Beatriz Rodriguez Grande, PhD

Regulatory Consultant and Consulting Manager

EU IVDR/MDR, In Vitro Diagnostics, Medical Writing, Trial Management, Worked for Notified Body

Carla Wiese

Carla M. Wiese, BS-Mech Eng

Principal Strategy Consultant, Regulatory

US FDA, Worked for US FDA

Caroline Guidicelli

Caroline Guidicelli, MSc, MEng

Principal Medical Writer

EU IVDR/MDR, Medical Writing

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