Meet Our Speakers

Miguel Amador

Chief Innovation Officer at Complear, Portugal

Miguel Amador is a Regulatory Expert in the field of Digital Health and AI, being one of the founders of… READ MORE

Alberto Bardaji

Head of Medical Devices at MDx, Spain

Alberto Bardají is the Head of Medical Devices at MDx, a leading EU-based CRO and regulatory consulting firm specializing in… READ MORE

Jennifer Bråten

Business Development Director, Meditrial, Switzerland

Bethany Chung

Director, Technical Solutions and Innovation, RQM+, USA

Bethany has a Ph.D. in biomedical engineering and loves all things quantitative. She has more than 10 years of experience… READ MORE

Quentin De Snoeck

PhD Researcher, Trinity College Dublin

Quentin de Snoeck, also known as QuentinMakesItClear, is a consultant specializing in Regulatory Affairs, Clinical Affairs, Product Management, Quality Assurance… READ MORE

Carlos Galamba

CEO, MDx CRO, UK

Carlos Galamba is the CEO and Head of IVD at MDx, a leading EU-based CRO and regulatory consulting firm specializing… READ MORE

Sharmila Gardner

Technical Documentation Manager & Head of UK Approved Body Intertek Medical Notified Body, UK

Sharmila has a dual role at Intertek as the Technical Documentation Manager – managing the TD assessment process, the technical… READ MORE

Danielle Giroud

CEO, MD-Clinicals, Switzerland

With over 30 years of experience within the medical device industry, Ms. Danielle Giroud is founder of MD-Clinicals ( https://www.md-clinicals.com), a… READ MORE

Hugh Harvey

Managing Director, Hardian Health, UK

Dr Harvey is an experienced clinician and health technology advisor, with a focus on leveraging big data and artificial intelligence.… READ MORE

Simon Lidgate

Technical Team Manager, AIMD Clinical, BSI, UK

I hold a doctorate in the numerical modelling of electromagnetics. After various roles involving the numerical modelling of electromagnetic and… READ MORE

Tom Melvin

Associate Professor of Medical Device Regulatory Science, University of Galway, Chair of the Regulatory Affairs Committee, Biomedical Alliance in Europe, Ireland

Tom Melvin is Associate Professor of Medical Device Regulatory Science at the University of Galway. Tom is Chair of the… READ MORE

Salvinia Mletzko

Associate Director Project Management, RQM+, Germany

Over 10 years of clinical trials experience in the pharmaceutical, medical device, digital therapeutics, and IVDR field (Research Institutions, Sponsors,… READ MORE

Natasha Motsi

AI Airlock Technical Programme Manager, MHRA, UK

Natasha Motsi is a Technical Programme Manager at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), where she leads the… READ MORE

Elisabeth Oltmanns

Managing Partner, Escentia, Germany

Elisabeth Oltmanns is a PhD candidate with Tom Melvin and her research focuses on the integration of clinical and non-clinical… READ MORE

Hatem Rabeh

Clinical Evaluation Expert for Medical Devices, Founder, Clinical Evaluation Navigator, France

Hatem Rabeh, MD, MSc, is a clinical evaluation expert specializing in helping Medical device companies meet MDR requirements with clarity and… READ MORE

Sally Sennitt

Director at Elsmere Enterprises, Belgium

EU physician and MedTech Regulatory Affairs professional. At my best with clinical strategy, CER, PMCF, Notified Body responses for any… READ MORE

Nebojsa Serafimovic

Assessor Medical Devices, Senior Expert, Austrian Agency for Health and Food Safety (AGES), Austria

Nebojsa Serafimovic is a Senior Assessor for clinical investigations with medical devices and performance studies with in vitro diagnostics at… READ MORE

Amie Smirthwaite

Independent Consultant, UK

Amie Smirthwaite is a clinical and regulatory affairs expert with over 30 years’ postdoctoral experience in medical devices spanning new… READ MORE

Monica Tocchi

Founder & CEO, Meditrial USA Inc.

Dr. Monica Tocchi is the CEO and Founder of Meditrial, a global contract research organization driving innovation in complex medical… READ MORE

Cécile van der Heijden

Advocaat / Attorney at law, Axon Lawyers, Netherlands

Cécile van der Heijden is an Amsterdam-based attorney-at-law, specialising in regulatory strategy, data governance, and innovation in the life sciences sector,… READ MORE

Anusha Venkatesan

AI Airlock Regulatory Specialist, MHRA, UK

Anusha Venkatesan is a seasoned regulatory professional with a robust background in SaMD regulatory intelligence, clinical safety reports, and risk management.… READ MORE

Tom Willshare

Co-founder and CTO of Revela, UK

Tom is Co-founder and CTO of Revela, a women’s health startup developing AI-powered tools to support earlier diagnosis of endometriosis.… READ MORE

Sarina Zillikens

Clinical Affairs Specialist, Escentia, Germany

Sarina Zillikens is a Clinical Affairs Specialist at Escentia GmbH, where she leads clinical evaluations in compliance with MDR for… READ MORE