Meet our Subject Matter Experts

David Mandley, PhD

Principal Regulatory Consultant

EU MDR, Medical Writing, Notified Body Expertise, Preclinical, Product Development, Regulatory

Frédéric Cadoret, PhD

Senior Study Director, Sterility Assurance

FDA, Microbiology, Notified Body Expertise, Validation

Jane Arnold-Round, MSc

Senior Principal Consultant, Regulatory

Clinical, EU MDR, Medical Writing, Notified Body Expertise, Regulatory

Kevin Butcher

Principal Regulatory Consultant

EU MDR, Notified Body Expertise, Quality, Regulatory

Matt Royle, PhD

Principal Regulatory Consultant

EU MDR, Notified Body Expertise, Product Development, Quality, Regulatory

Michelle Kelly, BSc, MSc, ERT

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, Notified Body Expertise, Toxicology

Paul Risborough, B-Eng (HONS)

Principal Regulatory Consultant

Notified Body Expertise, Regulatory

Pedro Eerdmans, MD, PhD

Director, Global Strategy Services

Clinical, Director, DSMB, EU MDR, FDA, Interventional & Surgical Research, Notified Body Expertise, Product Development, Regulatory

Rachel Gibbs, BSc, PhD

Principal Regulatory Consultant

Notified Body Expertise, Regulatory

Richard A. Vincins, BS, CMDA, CQA, RAC-Devices, M-TOPRA, CQP MCQI

Principal Strategy Consultant, Regulatory

EU IVDR, EU MDR, FDA, IVD, Medical Writing, Notified Body Expertise, Preclinical, Product Development, Quality, Regulatory, Validation

Thomas Miramond, PhD, MSc, M-Eng.

Senior Regulatory Consultant

EU MDR, Notified Body Expertise, Preclinical, Product Development, Quality, Regulatory

Warren R. Jameson, PhD

Senior Manager, Regulatory & Quality

Clinical, EU IVDR, FDA, IVD, Medical Writing, Notified Body Expertise, Quality, Regulatory

Let’s Talk About Your Project

Ask a question or request a meeting with a NAMSA expert to discuss your specific project. We will follow up as quickly as possible. Also, please tell us how you heard about NAMSA.

First Name*

Last Name/Surname*

Business Email*

Company*

Where are you based?*

State*

How can we help?

By choosing to submit your information to contact NAMSA, you are providing NAMSA consent to process and store your information on the NAMSA Network. At any time, you can submit a request to withdraw your consent for the use of information provided by you. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com.