Meet our Subject Matter Experts

A person with glasses and a goatee smiles against a neutral blue background.

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

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

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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

Caroline Guidicelli

Caroline Guidicelli, MSc, MEng

Principal Medical Writer

EU IVDR/MDR, Medical Writing

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Catherine Tremolieres, DVM

Manager, Biological Safety & Validation Consulting Services, Europe

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

Christèle East, PhD

Christèle East, PhD

Senior Regulatory Consultant, IVD

EU IVDR/MDR, Medical Writing

David Mandley, PhD

Principal Regulatory Consultant

EU IVDR/MDR, Medical Writing, Preclinical

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Don Pohl, BS

Principal Strategy Consultant, Biocompatibility

Biocompatibility, Biological Safety, EU IVDR/MDR, US FDA

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Gaëlle Clermont, PharmD, PhD

Principal Strategy Consultant

Biological Safety, EU IVDR/MDR, Medical Writing, Preclinical, US FDA

Jane Arnold-Round, MSc

Senior Principal Consultant, Regulatory

EU IVDR/MDR, Medical Writing, Worked for Notified Body

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Kevin Butcher

Principal Regulatory Consultant

EU IVDR/MDR, Worked for Notified Body

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