Speakers

Bassil Akra
CEO and Owner of AKRA TEAM GmbH, Germany
Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded in 2021 to… READ MORE
Ronald Boumans
TEAM-PRRC, The Netherlands
In 2022 Ronald started his own consulting service, where he helps companies solve complex problems, working as a PRRC, and… READ MORE
Koen Cobbaert
Senior Manager – Quality, Standards and Regulations at Philips, Belgium
Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents… READ MORE
Daniel Delfosse
Head of Regulation & Innovation Member of the Executive Board, Swiss MedTech, Switzerland
Daniel Delfosse, Dr.sc.techn., is Head of Regulation & Innovation and a member of the Executive Board at the industry association… READ MORE
Robert Ginsberg
EAAR Member of the Board, Chairman of the Board, QAdvis, Sweden
Robert Ginsberg is co-founder and Chairman of the Board of QAdvis, a Sweden based consulting company in medical device regulations.… READ MORE
Rob Higgins

Senior Regulatory Affairs Specialist, Medicines and Healthcare Products Regulatory Agency (MHRA), UK

Rob Higgins is a Senior Regulatory Affairs Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA). He has been… READ MORE
Alexandre Jauniaux
Head of Division Medical Devices, FAMHP, Belgium
Alexandre holds a master degree in biology with an orientation in biotechnology. He started his career in 2006 working in… READ MORE
Eric Klasen
CEO, Obelis GmbH, Switzerland
Consultant in Life Sciences and expert in Regulatory Affairs, QA, and Quality Management Systems Prior to retirement from Medtronic International… READ MORE
Alex Laan
Head of IVDs at BSI, Netherlands
Engineer (Dipl.-Ing) in Bioprocess technology and Biochemistry. Worked as a product specialist in immunohematological products and plasma products with Sanquin… READ MORE
Nils-Åke Lindberg
Member of the Board, EAAR; Founder of QAdvis, Sweden
Nils-Åke has more than 35 years of experience in the medical device industry. He is based in Sweden and as… READ MORE
Amanda Maxwell
Medtech Regulatory Affairs Editor, Medtech Insight, Informa Healthcare, UK
Amanda Maxwell is Medtech Regulatory Affairs Editor at Medtech Insight. She has some 30 years’ experience in reporting and providing… READ MORE
Ajda Mihelcic
EAAR Secretary; Manager of Publications dept., PA Unit Obelis, Belgium
Ajda holds a law degree and is heading the Publications department at Obelis, a leading authorized representative based in Brussels.… READ MORE
Ludger Möller
EAAR Chairman, President, Medical Device Safety Service, Germany
Ludger Moeller, Dipl. Ing. RWTH Aachen ▪ Executive Partner Medical Device Safety Service GmbH (MDSS) ▪ Founder MDSS Consulting GmbH,… READ MORE
Claire M. Murphy
EAAR Member of the Board, Consulting Partner, Tecno-med Ingenieros, SL, Spain
From Cork – Ireland Lives in the Penedès region near Barcelona, Spain Co-founder and Partner at Tecno-med Ingenieros S.L. (1995… READ MORE
Patrick Pille
MDSS, Germany
Starting in the PRRC Trainee Program in 2020, Dr. Patrick Pille is a Consultant at Medical Device Safety Service GmbH… READ MORE
Dario Pirovano
Senior Regulatory Affairs Adviser, MedTech Europe, Belgium
Dario Pirovano has over 30 years experience in Medical Technology, as designer and regulatory affairs expert. He worked for 7 years as R&D… READ MORE
Helene Quie
Member of the Board, EAAR, 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
Mika Reinikainen
UKRPA Chairman, Managing Director, Abnovo, UK
Mika Reinikainen is a founder and past Chairman of the European Association of Authorised Representatives (EAAR) and the current Chairman… READ MORE
Françoise Schlemmer
Team-NB Director (Medical Devices Notified Bodies Association), Belgium
Virginie Siloret
Global Medical Devices Certification Manager, SGS Belgium NV
Virginie Siloret is the Global Medical Device Certification Manager of the Notified Bod Belgium NB 1639 and was previously the… READ MORE
Thierry Sirdey
Co-chair of Competent Authorities for Medical Device Committee, France
Thierry Sirdey 22 years background in medical device field including 16 years in National Competent Authority. Co-chair of Competent Authorities… READ MORE
Maurizio Suppo
Member of the Board, EAAR, Co-owner & Principal Consultant, Qarad, Belgium
Co-owner and Principal consultant Maurizio Suppo (born 1960, Italian citizen) obtained his Ph.D. in molecular biology from the University of Turin (Italy)… READ MORE
Vishal Thakker
Head of UK Approved Body & Senior Regulatory Lead, Regulatory Services (Medical Devices) BSI UK, UK
Vishal joined BSI over 6 years ago and is currently the Head of the UK Approved Body and a Senior… READ MORE
Erik Vollebregt
Partner, Axon Lawyers, The Netherlands
Erik specialises in EU and national legal and regulatory issues relating to medical devices. He is an expert in life… READ MORE
Hanim Yassin
Policy Officer – SNE, Unit D.3 – Medical Devices, DG SANTE, European Commission
Hanim Yassin is a seconded national expert from Denmark, who joined the Commission in 2020. Before joining the Commission, she… READ MORE