Conference Speakers

  • Mika Reinikainen , UK I Conference Chair

    Mika Reinikainen , UK I Conference Chair

    Mika Reinikainen is a founder and Chairman of the European Association of Authorised Representatives (EAAR).  He is the founder of Abnovo Ltd, a medical device consulting company. Previously, he served in the position of Vice President at Quintiles. His company focuses on regulatory strategy and compliance, as well as resolving manufacturers’ conflicts with Notifies Bodies and Competent Authorities. 
  • Bassil Akra, Germany

    Bassil Akra, Germany

    Dr. Bassil Akra is the vice president of the global strategic business development at the medical health service of TÜV SÜD Product Service. Dr. Akra has long experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. 
  • Ronald Boumans, The Netherlands

    Ronald Boumans, The Netherlands

    Ronald is currently busy assisting Emergo clients to prepare for the MDR. He assists in developing and implementing regulatory strategies, corporate policies and complex change processes related to MDR compliance. He is also helps companies finding a suitable notified body, sometimes with very short timelines. 
  • Sandra Ferretti, Belgium

    Sandra Ferretti, Belgium

    Sandra Ferretti is the EAAR liaison officer and Chief Compliance Officer and Public Affairs Director at Obelis, a leading authorized representative based in Brussels. She represents the EAAR at various EUDAMED sub-groups (actors registration, device registration, vigilance, data-exchange), and also now at the MDCG work group on UDI, Vigilance, and IMDRF.
  • Robert Ginsberg, Sweden

    Robert Ginsberg, Sweden

    Robert Ginsberg is co-founder and Chairman of the Board of QAdvis, a Swedish based consulting company in medical device regulations. He specializes in software regulatory issues relating to medical devices and modern software engineering methods, for example Scrum or Lean software development. 
  • Erik Hansson, Belgium

    Erik Hansson, Belgium

    Deputy Head of the Health Technology and Cosmetics Unit of the DG for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) of the European Commission.
    Erik joined the cosmetics and medical devices unit of the European Commission in 2012 to lead the implementation of the PIP Action plan, followed by the negotiations on the new Regulations. 
  • Amanda Maxwell, UK

    Amanda Maxwell, UK

    Amanda Maxwell is Medtech Regulatory Affairs Editor at Medtech Insight.
    She has some 30 years’ experience in reporting and providing analysis on developments in the field of medical technology regulatory affairs, with particular focus on the current and future EU regulations for medical devices, IVDs and device/drug combination products.
  • Ludger Möller, Germany

    Ludger Möller, Germany

    Since 2000 President Medical Device Safety Service GmbH (MDSS)
    Founder MDSS Consulting and ITN Holding GmbH
    Co-Founder and Vice-Chairman European Association of Authorized Representatives (EAAR)
    1996-2000 Lead Auditor and Expert with leading Notified Body (TÜV Rheinland)
  • Dario Pirovano, Belgium

    Dario Pirovano, 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 and regulatory manager with Ohmeda in Milan signing some 20 project for anesthesia machines, lung ventilators and neonatal care devices. He worked for 4 years within the Commission of European Communities where he contributed to the drafting and negotiating 90/385 /EEC and 93/42/EEC directives. 
  • Françoise Schlemmer, Belgium

    Françoise Schlemmer, Belgium

    After a master's degree in biochemistry, she worked for Medical Device Manufacturers, a Notified Body and set up Quasys Consult consultancy.
    Quasys Consult mainly helps manufacturers of medical devices to obtain the CE mark.

  • Sarah Sorrel, France

    Sarah Sorrel, France

    Sarah Sorrel has more than 30 years of experience of medical device regulation and clinical trials with an emphasis on emerging technologies. 
    She is founder and President of MedPass International, the leading European CRO and consultancy for the development and market access of new medical technologies. 
  • Kirsten Van Garsse, Belgium

    Kirsten Van Garsse, Belgium

    Kirsten Van Garsse obtained her Master’s degree in Biomedical Sciences in 2002 from the Vrije Universiteit Brussel (VUB) and has gained extensive experience working in the In Vitro Diagnostic Medical Device Industry in various roles. She joined Qarad, a consulting company specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry, at the end of 2017.
  • Erik Vollebregt, The Netherlands

    Erik Vollebregt, The Netherlands

    Erik specialises in EU and national legal and regulatory issues relating to medical devices. He is an expert in life sciences regulation at EU and Dutch level. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission.