Meet our Subject Matter Experts

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Adrian Keene

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

Biological Safety, Cardiology, EU IVDR/MDR, Medical Writing, Neurology, Orthopedics, Vascular, Worked for Notified Body, Wound Care

Andy J. Wyen, MS, DABT, LAT

Principal Toxicologist

Biocompatibility, Biological Safety, Cardiology, Chemical Characterization, EU IVDR/MDR, Neurology, Ophthalmology, Orthopedics, Software, Toxicology, US FDA, Vascular, Wound Care

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Angela Sanchez

Associate Scientific Director, Analytical Services

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

Aurélie San Juan, MSc, PhD

Principal Medical Writer, Regulatory

EU IVDR/MDR, Medical Writing, Ophthalmology, Orthopedics, Vascular

Caroline Guidicelli

Caroline Guidicelli, MSc, MEng

Principal Medical Writer

EU IVDR/MDR, Medical Writing, Orthopedics, Software, Vascular

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Catherine Tremolieres, DVM

Manager, Biological Safety & Validation Consulting Services, Europe

Biocompatibility, Biological Safety, Cardiology, Chemical Characterization, EU IVDR/MDR, Neurology, Ophthalmology, Orthopedics, Toxicology, US FDA, Wound Care

Christèle East, PhD

Christèle East, PhD

Senior Regulatory Consultant, IVD

EU IVDR/MDR, In Vitro Diagnostics, Medical Writing

David Mandley, PhD

Principal Regulatory Consultant

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Don Pohl, BS

Principal Strategy Consultant, Biocompatibility

Biocompatibility, Biological Safety, Cardiology, Chemical Characterization, EU IVDR/MDR, Neurology, Ophthalmology, Orthopedics, Software, Toxicology, US FDA, Vascular, Wound Care

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Gaëlle Clermont, PharmD, PhD

Principal Strategy Consultant

Biocompatibility, Cardiology, EU IVDR/MDR, Neurology, Ophthalmology, Orthopedics, Preclinical, US FDA, Vascular, Wound Care

Jack Risdahl, DVM, PhD

Principal Strategy Consultant, Preclinical

Cardiology, EU IVDR/MDR, Neurology, Ophthalmology, Orthopedics, Preclinical, US FDA, Vascular, Wound Care

Jane Arnold-Round, MSc

Senior Principal Consultant, Regulatory

Cardiology, EU IVDR/MDR, Neurology, Ophthalmology, Orthopedics, Vascular, Worked for Notified Body, Wound Care

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Kevin Butcher

Principal Regulatory Consultant

EU IVDR/MDR, Software, Worked for Notified Body

Lucile Ryckebusch, PhD

Senior Medical Writer

EU IVDR/MDR, In Vitro Diagnostics, Medical Writing, Software

Marie-Charlotte Notargiacomo

Senior Biological Safety Scientist

Biocompatibility, Biological Safety, Cardiology, EU IVDR/MDR, Medical Writing, Neurology, Ophthalmology, Orthopedics, Vascular, Wound Care

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