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

Niall MacAleenan

Medical Device Lead, Health Products Regulatory Authority (HPRA), Ireland

Niall is the Medical Device Lead and Clinical Assessment & Policy Manager for medical devices at the Health Products Regulatory Authority (HPRA) in Ireland. At the HPRA he is responsible for coordinating medical device activities with specific operational focus on market surveillance of medical devices, notified body designation & oversight and assessment of clinical investigations and clinical evaluation of medical devices.

Niall is a member of a number of different EU working groups on medical devices including the Medical Device Expert Group (MDEG), the Medical Device Regulatory Committee, the Clinical Investigation and Evaluation Working Group (CIEWG) and the Notified Body Operations Group (NBOG). He is a member of the European delegation to the Management Committee of the International Medical Device Regulators Forum (IMDRF).

Niall is a medical doctor with a broad experience in hospital medicine having completed general professional training in internal medicine. Niall’s clinical research interests included endoscopic screening for gastrointestinal malignancy and antimicrobial resistance patterns for Helicobacter pylori. In addition to his medical degree, Niall also holds a Masters in Business Administration.

niall.macaleenan@hpra.ie

+353 1 6343428

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