sitem Center for Translational Medicine and Biomedical Entrepreneurship

Standalone Modules

Module 4 - EU Medical Device Regulations Part C

 

Content

Module 4 is comprised of three submodules covering the regulation of labelling and inst-ructions for use, conformity assessment and product registration, and post market surveillance and post market clinical follow-up.

We will add more information about this module soon. If you are interested to learn specific information in the meantime, please contact us. 

Start & Duration

2020: 19 April 2021
2021: TBC

The completion of this module takes approximately 10 weeks.

Credits

6 ECTS

Fee

The cost of this standalone module is 6'300.– SFr.

Reference

03.004

 

Module Leaders

Independent Consultant

Dr. Jürgen Berndt

Jürgen Berndt has more than 30 years of experience in regulated industries including 18 years with 3M, where he was the European lead of the Quality and Regulatory functions for 8 years. He retired from his employment in various Regulatory Affairs leadership roles in May 2020 and now shares his knowledge and experience as a lecturer of the Medical Device Regulatory Affairs and Quality Assurance study program at the University of Bern.

Founder, Chairman and CEO of confinis ag (Switzerland and USA)

Beat U. Steffen

Beat U. Steffen, Founder, Chairman & CEO of confinis ag, (Switzerland and USA) holds a MSc in electrical engineering an executive MBA and has 25+ years of experience in medical device and combination product development/manufacturing/quality management/regulatory affairs. In addition to confinis, he co-founded Medical Human Factors AG in 2016, a company specialized in evaluating the use-related safety, effectiveness and usability of medical products and confinis CPM in 2018, a virtual workplace that provides senior-level clinical project staff and functional service professionals to gather clinical data.

Regulatory Affairs Manager / Product Manager, DQS Medizinprodukte GmbH

Szymon Kurdyn

Competence Cluster Lead & Senior Consultant, confinis ag

Dr. Andrea Biasiucci

Dr. Andrea Biasiucci is an Electronic and Biomedical engineer with a PhD in Brain-Machine Interfaces from the Swiss Federal Institute of Technology Lausanne (EPFL) and more than 10 years of experience in medical device innovation and digital health. At confinis, he leads the Competence Cluster in Clinical Evaluation, Active Implantable Medical Devices and Digital Health.