Meet our Subject Matter Experts

Adrian Keene

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

Biological Safety, Clinical, EU IVDR, EU MDR, Regulatory

Áine Mary Duffy, BSc (Hons), PhD

Clinical & Regulatory Operations Manager

Clinical, EU MDR, FDA, Medical Writing, Regulatory

Ariadna Navarro, PhD

Senior Strategy Consultant

Clinical, EU IVDR, EU MDR, IVD, Medical Writing, Quality, Regulatory

Jane Arnold-Round, MSc

Senior Principal Consultant, Regulatory

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

Lucile Ryckebusch, PhD

Senior Medical Writer, IVD

Clinical, EU IVDR, EU MDR, IVD, Medical Writing

Pedro Eerdmans, MD, PhD

Director, Global Strategy Services

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

Sara Finocchietti, MEng, PhD

Senior Strategy Consultant, Clinical

Clinical, EU MDR, Product Development, Regulatory

Séverine Oudin-Fantin, PhD

Manager–EMEA Medical Writing Services

Clinical, EU MDR, Medical Writing

Wendy Schroeder, BSN, CCRC/PM, CRCP

Principal Strategy Consultant, Clinical

Clinical, EU IVDR, EU MDR, FDA, IVD, Regulatory

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