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

Dr. Matthias Neumann (Deputy Chair)

Federal Ministry of Health (Bundesministerium fuer Gesundheit – BMG), Germany

Matthias Neumann has been working at the Federal Ministry of Health since 2002. In his unit “Medical Devices Safety” he has to deal with all aspects related to national, European and international medical devices regulation. He studied physics, medical physics and biophysics. He worked for the industry in a R&D department on the development of gas analysers. He finished his 5 years work for the Institute for Medical Physics and Biophysics of the University Hospital Charité with a dissertation on measurements methods of blood cell mechanics.

Matthias has trained as a quality management officer for a medical devices start-up and worked for one year for the Federal Office of Radiation Protection in the field of non-ionising radiation in medicine.

In his time (1997-2002) at the Federal Institute for Drugs and Medical Devices (BfArM) he was responsible for the risk-assessment of active medical devices (including AIMD), involved in incidents or field safety corrective actions.

He has more than 15 years of experience in the field of medical devices regulation, vigilance, risk management, standardisation, etc. He is member of various European and international working or standardisation groups, e.g. as European representative in the IMDRF-Management Committee or IMDRF Project group on “UDI” or “List of recognized standards”, or convener of the Joint CEN/CENELEC Group on “Active Implantable Medical Devices”.

matthias.neumann@bmg.bund.de

+49 301 844 12636

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