Meet our Subject Matter Experts

Adam E. Saltman, MD, PhD

Chief Medical Officer

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

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

Carla Wiese

Carla M. Wiese, BS-Mech Eng

Principal Strategy Consultant, Regulatory

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

Chad Reiter, PhD, DABT

Biocompatibility, Cardiology, Orthopedics, Toxicology, Worked for US FDA, Wound Care

Jane Arnold-Round, MSc

Senior Principal Consultant, Regulatory

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

Person in a dark suit and light tie standing by an open white door.

Kevin Butcher

Principal Regulatory Consultant

EU IVDR/MDR, Software, Worked for Notified Body

Matt Royle, PhD

Principal Regulatory Consultant

EU IVDR/MDR, Orthopedics, Worked for Notified Body

Michelle Kelly, BSc, MSc, ERT

Biocompatibility, Biological Safety, Cardiology, Chemical Characterization, EU IVDR/MDR, Neurology, Ophthalmology, Orthopedics, Toxicology, Worked for Notified Body, Wound Care

Smiling person in a black top with light-colored hair against a plain background.

Rachel Gibbs, BSc, PhD

Principal Regulatory Consultant

EU IVDR/MDR, Worked for Notified Body, Wound Care

Sarah B. Nelson, MS

Senior Strategy Consultant, Regulatory

In Vitro Diagnostics, Orthopedics, US FDA, Worked for US FDA, Wound Care

Thomas Miramond, PhD, MSc, M-Eng.

Senior Regulatory Consultant

Biocompatibility, Chemical Characterization, EU IVDR/MDR, Medical Writing, Orthopedics, Preclinical, Worked for Notified Body

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