Meet Our Speakers

Stuart Angell

Managing Director, IVDeology, UK

As the Managing Director and Co-founder of IVDeology, Stuart brings over 20 years’ experience within the IVD industry. Stuart is… READ MORE

Edward Ball

Manager, Intelligence and Strategic Execution at RQM+, UK

Ed Ball is part of RQM+’s Intelligence & Innovation team. He is a Chartered Engineer (CEng) and holds a MSc… READ MORE

Anna Bertilsson

Senior Director, Integra Life Sciences, Sweden

Michael Branagan-Harris

Founder & CEO, Device Access, UK

Since 1989, Michael Branagan-Harris, CEO of Device Access UK Ltd has been involved in accelerating patient access to great technology… READ MORE

Josh Bridgens

European Medical Director for J&J Medtech, UK

Joshua Bridgens is European Medical Director for J&J Medtech. He has a focus on orthopaedic implants and has been involved… READ MORE

Bethany Chung

Senior Manager, Technical, 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

Sara Contu

Product Manager for Fern.ai, Giotto.ai, Switzerland

Sara Contu is a Product Manager at Fern.ai, where she works on product discovery and delivery, focusing on simplifying regulatory… 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

Ella Helgeman

Director, Regulatory Affairs and Quality Assurance, Rehaler, Denmark

Ella Helgeman is an accomplished Regulatory and Quality Director with over 20 years of experience in the medical device industry… READ MORE

Richard Holborow

Global Head Clinical Compliance, BSI, UK

Richard Holborow BSc (Hons) MSCST RCCP Global Head of Clinical Compliance for BSI Notified Body (NL) & BSI Approved Body… READ MORE

Breda Kearney

Clinical Regulatory Lead, Global Regulatory Compliance Team, BSI Group, Ireland

Breda Kearney recently joined BSI as a Clinical Regulatory Lead and has extensive experience in Clinical Regulatory Compliance gained through… READ MORE

John Kilmartin

Medtech Regulatory Consultant & Adjunct Professor, University of Galway (Inst. for Clinical Trials), Ireland

John Kilmartin – Adjunct Professor at the Institute for Clinical Trials (University of Galway, Ireland) and independent MedTech Regulatory Advisor.… READ MORE

Ewa Lindqvist

Director, THREAD Research

Over 2 decades delivering global clinical trials with more than 10yrs in management and leadership positions. Passionate about the power… READ MORE

Mattias Kyhlstedt

CEO and Founder, Synergus RWE, Sweden

Mattias is the CEO and founder of Synergus RWE, providing market access services in Western Europe and Real-World Evidence studies… READ MORE

John McDonald

Senior Director Clinical Evidence Generation, Teleflex, Ireland

John McDonald Ph.D, Senior Director Clinical Evidence Generation at Teleflex. I joined Teleflex 2010. I worked as Director of Regulatory… 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,… READ MORE

Heike Möhlig-Zuttermeister

Global Director in-vitro Diagnostics (IVD) at Tüv Süd, Germany

Heike is leading the IVD team at TÜV Süd since December 2022. Before joining TÜV Süd Heike spent 8 years… READ MORE

Sarah Panten

Co-Founder, Medical Device Knowledge Unit (MDKU), Germany

Sarah has a background in medical technology and has worked in various positions since 2007. Initially, she worked as an… READ MORE

Paul Piscoi

European Commission, Belgium

Helene Quie

Founder & CEO, Qmed Consulting, Denmark

Helene Quie has a master’s degree in science specialised within Cellbiology from the University of Odense. Helene has more than… READ MORE

Prof. Frank Rademakers

UZ KU Leuven, Belgium

Frank Rademakers is emeritus professor at KU Leuven, Belgium. He retired in 2020 from his managerial position at UZ KU… READ MORE

Sally Sennitt

Medical Director, RQM+, Belgium

Sally Sennitt MBBS, FRCA is currently the medical affairs director at RQM+ focusing on clinical aspects of pre-market MDR CE… READ MORE

Nebojsa Serafimovic

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

Mr Nebojsa Serafimovic is an assessor for clinical investigations with medical devices and performance studies with in vitro diagnostics at… READ MORE

Amie Smirthwaite

Senior Vice President, Intelligence and Innovation RQM+, UK

Amie Smirthwaite has a PhD in biomedical engineering and undergraduate degrees in biomedical engineering and mathematics. She has 30 years’… READ MORE

Mette Sørensen

Internal Clinician, TÜV SÜD, Denmark

Mette Sørensen is a registered nurse by training and have been working nine years in the gynaecology area with research.… READ MORE

Ashley Stratton-Powell

Expert Assessor at the MHRA, UK

Ashley is an Expert Benefit Risk Evaluation Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) with expertise in… READ MORE

Oge Swaby

Principal Business Consultant at NEC Software Solutions, UK

Oge Swaby is a Principal Business Consultant at NEC Software Solutions, specialising in health informatics with a focus on health… READ MORE

Ankeet Tanna

Consultant, Hardian Health, UK

Ankeet is a medical doctor with experience in developing machine learning tools for healthcare during his training at Cambridge. Since… READ MORE

Dr. Vicky Valla (Ph.D., M.A., DipTrans)

Regulatory Compliance Lead, Evnia, Denmark

Cécile van der Heijden

Advocaat / Attorney at law, Axon Lawyers, Netherlands

Cécile is Axon Lawyers’ data protection and privacy expert. As a senior attorney-at-law and CIPP/E-certified privacy-specialist with a background in… READ MORE

Efstathios Vassiliadis

CEO, Evnia, Denmark