Meet our Subject Matter Experts

Adam E. Saltman, MD, PhD

Chief Medical Officer

Cardiology, Software, US FDA, Worked for US FDA

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

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

Carla Wiese

Carla M. Wiese, BS-Mech Eng

Principal Strategy Consultant, Regulatory

US FDA, Worked for US FDA

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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

Chris Mullin, MS

Director, Global Strategy Services

Biostatistics, Cardiology, Neurology, Ophthalmology, Orthopedics, US FDA

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Cindy Dingee, DVM

Histopathology Operations Manager and Veterinary Pathologist

Biocompatibility, Biological Safety, Preclinical, US FDA

Dan Fowler

Group Manager, Reprocessing and Sterilization Validation Services

Microbiology, Preclinical, US FDA

A person in a green shirt stands in a hallway with blurred background.

Don Pohl, BS

Principal Strategy Consultant, Biocompatibility

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

Ed Arscott, BS

Principal Strategy Consultant, Microbiology

Microbiology, US FDA

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Frédéric Cadoret, PhD

Senior Study Director, Sterility Assurance

Microbiology, US FDA

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Gaëlle Clermont, PharmD, PhD

Principal Strategy Consultant

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

Jack Risdahl, DVM, PhD

Principal Strategy Consultant, Preclinical

Preclinical, US FDA

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