Bernhard Bichsel

Head of Medical Devices Division, Swissmedic, Switzerland

Bernhard joined Swissmedic in 2012 as Head of Medical Devices Division. He has a broad background on Medical Devices issues, such as Clinical Investigation, Vigilance, Market Surveillance and Notified Bodies. He has sound project management experience.

Prior to his current position, Bernhard was responsible for verification and validation issues in a major medical device company. He originally started his career as an Engineer in the industry and focused on production, component testing, quality systems and supplier audits.

Bernhard graduated in Electrical Engineering, followed by an Executive MBA in general management at the University of St. Gallen.

bernhard.bichsel@swissmedic.ch

Dr. Helena Dzojic

Head of Department of Medical Devices, the Medical Products Agency, Sweden

Helena Dzojic holds a PhD in Clinical Immunology from Uppsala University and has nearly five years of research experience within the field of immunotherapy. Since 2011 she has held the role of Head of the Department for Medical Devices at the Medical Products Agency in Sweden where she has had several roles since 2007. Helena also has broad experience in the field of regulation and market surveillance of medical devices.

Furthermore, she has experience of working in several EU working groups such as MD IVD, MD Compliance & Enforcement (COEN) WG, Medical Devices Experts Group (MDEG) and MD Regulatory Committee. She is also member of The Market Surveillance Council, a national coordination body for market surveillance in Sweden.

helena.dzojic@mpa.se

+46 70 213 95 03

John Wilkinson OBE

Director of Devices, MHRA, United Kingdom

John Wilkinson has been Director of Devices at the Medicines and Healthcare products Regulatory Agency since February 2012. Prior to this he was Chief Executive of Eucomed, the European medical technology industry association. He is currently chair of the Competent Authorities Medical Devices (CAMD) Executive, which is seeking to enhance collaboration between European member states and the European Commission in developing and managing the EU medical devices regulatory system.

His earlier experience included the role of Director General of the Association of British Healthcare Industries and a number of roles in the medical devices industry, both in the UK and the USA, with Becton Dickinson and the BOC Group. These were followed by a period as Chief Executive of an early stage medical imaging company.

John holds a first degree in Zoology from the University of Aberdeen and an MBA from the University of Warwick. He was awarded an OBE for services to the medical devices industry in the 2010 New Year’s honours list.

john.wilkinson@mhra.gov.uk

+44 20 3080 7900

Newsletter Sign up