Meet our Subject Matter Experts

Adam E. Saltman, MD, PhD

Chief Medical Officer

Cardiology, Medical Writing, Software, US FDA, Vascular, Worked for US FDA

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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

Áine Mary Duffy, BSc (Hons), PhD

Associate Director, Clinical Strategy

Medical Writing, Neurology, US FDA, Vascular

Person in a dark suit and red-striped tie, smiling in a well-lit environment.

Alexander Hermann, PhD

Manager, Technical Study Management

Biological Safety, Cardiology, Chemical Characterization, Neurology, Ophthalmology, Orthopedics, Software, US FDA, Vascular, 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

Candace McClure, PhD

Senior Principal Biostatistician

Biostatistics, Cardiology, In Vitro Diagnostics, Neurology, US FDA, Vascular

Carla Wiese

Carla M. Wiese, BS-Mech Eng

Principal Strategy Consultant, Regulatory

Cardiology, Neurology, Ophthalmology, US FDA, Vascular, Worked for US FDA

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

Chris Mullin, MS

Director, Global Strategy Services

Biostatistics, Cardiology, Medical Writing, Neurology, Ophthalmology, Orthopedics, Software, US FDA, Vascular, Wound Care

Christèle East, PhD

Christèle East, PhD

Senior Regulatory Consultant, IVD

EU IVDR/MDR, In Vitro Diagnostics, Medical Writing

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Cindy Dingee, DVM

Senior Pathologist

Biocompatibility, Biological Safety, In Vitro Diagnostics, Orthopedics, Preclinical, Toxicology, US FDA, Wound Care

David Mandley, PhD

Principal Regulatory Consultant

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