Speakers

  • Mika Reinikainen , UK I Congress Chair

    Mika Reinikainen , UK I Congress 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. 
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  • Ronald Boumans, The Netherlands

    Ronald Boumans, The Netherlands

    Ronald’s work currently focusses on Clinical Evaluation Reports for high risk devices, but he also helps manufacturers with strategic decisions. He has a wide range of experience in borderline cases, where the product status is not immediately clear or where the risk class is an issue. He is also involved in market surveillance cases, where competent authorities need to be informed adequately. Within Emergo he concentrates on the transition from the Directives to the Regulations.
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  • Sandra Ferretti, Belgium

    Sandra Ferretti, Belgium

    With a near to 20 years of employment at Obelis s.a. as Chief Compliance Officer, Sandra Ferretti  has a unique expertise in European regulatory affairs both in cosmetics and medical devices fields. Her specialties: Regulatory affairs, cosmetics, medical devices, responsible person, authorized representation, quality assurance, policy making, European associations representation, company law, social law, business administration, public subventions. 
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  • Robert Ginsberg, Sweden

    Robert Ginsberg, Sweden

    Robert specializes in software regulatory issues relating to medical devices and modern software engineering methods, for example Scrum or Lean Software development.
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  • Roger Gray. Italy

    Roger Gray. Italy

    Based in the United Kingdom (UK), Roger Gray has worked for over 35 years in the medical device industry, specializing in European and United States regulatory and quality management requirements, in particular for electro-medical, minimally invasive and associated devices.
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  • Hans-Heiner Junker, Germany

    Hans-Heiner Junker, Germany

    Hans-Heiner Junker has studied in Hamburg Bio-Engineering and joined in February 1980 TÜV in Hanover in the newly established department of Product Safety. 
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  • Hanneke Later-Nijland, The Netherlands

    Hanneke Later-Nijland, The Netherlands

    Hanneke is both a lawyer and a pharmacist. She specialises in EU and national legal and regulatory issues relating to medicinal products
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  • 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.
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  • Ludger Möller, Germany

    Ludger Möller, Germany

    Ludger Möller is a founder and Vice-Chairman of the European Association of Authorized Representatives (EAAR).
    He is the President of Medical Device Safety Service GmbH (MDSS) and Chairman of MDSS Consulting and ITN Holding GmbH 
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  • Dario Pirovano, Europe

    Dario Pirovano, Europe

    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. 
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  • 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. 
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  • Maurizio Suppo, Belgium

    Maurizio Suppo, Belgium

    Maurizio Suppo, trained as a molecular biologist, has 30 years of experience in Quality & Regulatory in international medical device and in-vitro diagnostic industry. He has been the Director of EDMA (European Association of In-Vitro Diagnostic Manufacturers) from 95 to 98 and in those years he has played a fundamental role in the drafting process of the EU IVD-Directive (98/79/EC) by representing the IVD industry at the EU Commission, EU Parliament and EU Council.
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  • Graeme Tunbridge, UK

    Graeme Tunbridge, UK

    Graeme is Group Manager for Devices Regulatory Affairs at the Medicines and Healthcare products Regulatory Agency (MHRA). 
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