Speakers

Meet the Speakers

Bassil Akra

CEO, Qunique GmbH, Germany

Dr. Bassil Akra is the CEO and co-owner of QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and… READ MORE
Ronald Boumans

EAAR Member of the Board, Senior Global Regulatory Consultant, Emergo, The Netherlands

Ronald is currently busy assisting Emergo clients to prepare for the MDR. He assists in developing and implementing regulatory strategies,… READ MORE
Maria E. Donawa

Member of the Board, EAAR, President, Donawa Lifescience, Italy

Maria E. Donawa, MD is President, Donawa Lifescience, headquartered in Rome, Italy, with over 30 years’ regulatory experience, including six… READ MORE
Helena Dzojic

Head of Department for Medical Devices, The Swedish Medical Products Agency, Sweden

Member of the Executive Group of the Competent Authorities for Medical Devices (CAMD), Head of Department of Medical Devices, the… READ MORE
Sandra Ferretti

EAAR Member of the Board, Chief Compliance Officer, Obelis, Belgium

Sandra Ferretti is the EAAR liaison officer and Chief Compliance Officer and Public Affairs Director at Obelis, a leading authorized… READ MORE
Robert Ginsberg

EAAR Member of the Board, Chairman of the Board, QAdvis, Sweden

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Erik Hansson

Deputy Head of Unit, European Commission, Directorate General for Health and Food Safety (SANTE) Medical Devices and Health Technology Assessment Unit, Belgium

Deputy Head of Unit, European Commission, Directorate General for Health and Food Safety (SANTE) Medical Devices and Health Technology Assessment… READ MORE
Anne Jury

Vice-President, Team-PRRC, UK

Anne Jury is a consultant and trainer in medical devices EU & UK regulatory compliance and quality assurance systems.  Starting… READ MORE
Mindy McCann

VP Regulatory Compliance, Qserve Group, USA

Mindy has multi-faceted medical device regulatory experience, having worked for a start-up, large global company and two notified bodies before… READ MORE
Mika Reinikainen.

Chairman, UKRPA

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Ludger Möller

EAAR Vice-Chairman, President, Medical Device Safety Service, Germany

Since 2000 President Medical Device Safety Service GmbH (MDSS) Founder MDSS Consulting and ITN Holding GmbH 1996-2000 Lead Auditor and… 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 Academic Background: Degree in Electrical and Electronic Engineering… 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 degree in Science specialised within cell biology from the University of Odense. Helene has 25 years… READ MORE
Mika Reinikainen

Chairman of the Board, EAAR; Managing Director, Abnovo, UK

Mika Reinikainen is a founder and Chairman of the European Association of Authorised Representatives (EAAR). He is the founder of… READ MORE
Merlin Rietschel

Senior Manager Regulations & Industrial Policy, MedTech Europe, Belgium

Merlin Rietschel is currently the leading coordinator of activities related to Notified Bodies at MedTech Europe. He previously held the… 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… READ MORE
Gavia Taan

Unit Manager – Devices Regulatory Policy, Devices Division, Medicines and Healthcare Products Regulatory Agency, UK

Gavia is Unit Manager for Devices Regulatory Policy at the Medicines and Healthcare products Regulatory Agency (MHRA). She is responsible… 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
Klaus-Dieter Ziel

Managing Director, MEDCERT GmbH, Germany

After more than 10 years in industry, working for 2 medical devices manufacturers, Klaus-Dieter Ziel was one of the founding… READ MORE
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