Speakers at Medtech Copenhagen 2021
Director of Clinical Audit, TÜV SÜD
Dr. Susanne Gerbl-Rieger, born 1958 in Munich studied molecular biology, genetic engineering, human genetics, and pharmacology at the Ludwig Maximilian University in Munich, Germany. She received her doctorate in 1990 at the Max Planck Institute for Biochemistry, Technical University of Munich, and started working for TÜV SÜD in 1992, focusing on quality and safety topics in life science. At TÜV SÜD, she worked as expert in genetic engineering and biotechnology, as quality management system auditor for life science companies and as reviewer of design dossiers of medical devices at a European Notified Body. She built up a food and feed certification business and became the CEO and head of the Certification Body of TÜV SÜD Vitacert GmbH. From 2008 – 2016 she was Director for Compliance at MSOURCE and later CROMSOURCE, a European and US based CRO. At the same time, (2012-2016) she was the chairman of the medical device working group of European Federation of Clinical Research Organisations (EUCROF). She continuously maintained her authorization as medical devices auditor at TÜV SÜD Product Service GmbH. In 2016, she joined the Clinical Centre of Excellence (CCE) of TÜV SÜD as Director for Clinical Audits. From 2016 on her focus is the implementation of the clincial aspects of the european medical device regulation (MDR) within the conformity assessment actvities of the TÜV SÜD Notified Body.
Clinical Leader at EDP Solutions, Phillips Medical Systems
Maastricht Area, Netherlands
Experienced professional in the area of implantable medical devices (incl. pacemakers, ICDs, CRT, Heart Failure, cardiac monitoring) and electrophysiology; working experience in international clinical research, medical affairs, and market development.
Klaas Van’T Klooster
Manager External Research at DePuy Synthes Companies and member of ISO/TC 194 WG4
Utrecht Area, Netherlands
Klaas van ’t Klooster holds a BA in Physical Therapy and a MSc in Applied Life Sciences. After several years of practicing Physical Therapy in Switzerland and the US he moved in 2000 into the Orthopedic Medical Device industry where he held various Clinical Research positions. These Clinical Research roles involved both company organized and Investigator Initiated Studies. Klaas is since 2005 a member of the Dutch standards (mirror) committee revising the ISO 14155 and as such involved in the publication of the 2011 version. Since 2014 the process started to revise the 2011 version which is now close to finalization.
Senior Clinical Study Manager, Smith and Nephew
7+ years experience in medical device industry (trial management, clinical evidence & evaluation, etc.) with 2 years of managerial experience.
Rahel is working in clinical operations and have a small team of project managers. She also works with the data privacy team to ensure compliance with data privacy standards. She is the first-level contact for the clinical and medical affairs teams for questions and issues on data privacy.
Thomas Wejs Møller
Section Manager – Medical Devices at the Danish Medicines Agency
As Head of Unit (section manager) and responsible for medical devices in the Danish Medicines Agency Thomas works with public sector, MedTech-Industy and Patient-NGO’s to secure patient safety.
Experienced manager in the public sector. I have worked with key projects in Local Government Denmark, Danish Regions(Healtcare sector) and State Government.
Achivement of top results with strategy, efficiency and management projects in healthcare and government. Thomas built and managed organizations and thus has profound experience in delivering progress and governance in complex organizations.
Thomas holds a degree in political science from the University of Copenhagen, has several courses and continuing education in project management and leadership and has several years of management experience.
CEO & Chairman, ECLEVAR
Real-world, non-identified patient data is a critical for gathering clinical evidence. It requires new techniques such as machine learning and artificial intelligence to dig the insights out.
Since our foundation in Paris, our mission has been to help our clients to accelerate the development of medical devices and drugs that save lives and improve quality of life.
We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality.