Friday, 9 December, 1PM -2:30PM CET

Zoom Link: ethz.zoom.us/j/61791835498

About Dietmar Schaffarczyk

Dietmar Schaffarczyk is one of the Regulatory Experts@ETHzurich, a Senior Consultant and Director Regulatory Affairs International (Univ. Lübeck) in medtech  industry. In addition, Dietmar is a Dipl. Lead Auditor (SAQ / EOQ) for Quality Management Systems (ISO 13485 / ISO 27001) and Lead Technical Assessor for Medical Devices, SaMDs, In-Vitro Diagnostics and PPE. Dietmar also works as Medical Writer (EMWA) and Clinical Investigator (ConsaMED) and is Lecturer at ETH, GdCH and German 4C Accelerator for Healthtech Products. He is author of several publications and books about regulatory, design and development and certification and is editor in chief of MedDEV News.

About the Lecture

The lecture will cover a number of topics relating to regulation, such as “what makes the difference: MedTech products vs. lifestyle products?”, or “How do certification processes differ between Switzerland and the EU?”. The talk will look at how much time and finances digital health start-ups should plan in for regulatory and certification pathways.

Additional topics covered will include data protection and security, e.g.  the handling of patient data. Dietmar will further address common challenges during the design and development phase of AI, SOUP and Agile Development products. To round off the talk, there will be time for questions and discussions from the audience.

We are pleased to invite you to join this guest lecture. Registration is not required. If you have any questions, please contact Olivia Keller (olkeller@ethz.ch) prior to the start of the guest lecture.

Prof. Dr. Tobias Kowatsch, Associate Professor for Digital Health Interventions, Institute for Implementation Science in Health Care, University of Zurich; Director, School of Medicine, University of St.Gallen (HSG); Scientific Director, Centre for Digital Health Interventions (CDHI), ETH Zurich & HSG; Principal Investigator, Future Health Technologies programme, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore

Prof. Dr. Elgar Fleisch, Professor of Information Management, ETH Zürich; Professor of Technology Management, University of St.Gallen; Advisory Board Member, CDHI, ETH Zürich & University of St.Gallen; Principal Investigator, Future Health Technologies programme, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore

Prof. Dr. Florian von Wangenheim, Professor of Technology Marketing, ETH Zurich & Advisory Board Member, CDHI; Principal Investigator, Future Health Technologies programme, Campus for Research Excellence and Technological Enterprise (CREATE), Singapore-ETH Centre, Singapore