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Guest Lecture by Hansjörg Riedwyl on Software as Medical Device, Oct 16, 2019

Wednesday, October 16, 2019, 4:15 pm – 6:00 pm
University of St.Gallen, Dufourstrasse 50, Room 09-011 (Map)

About Hansjörg Riedwyl

Hansjörg Riedwyl is a founding member and the managing director of Integrated Scientific Services (ISS), a major service provider for the MedTech industry in Switzerland. He is an expert in business development, considering strategic and operative regulatory and clinical aspects. Due to many years of experience as CEO and project manager and as co-founder and board member of several MedTech start-ups, he brings along a deep insight into strategic challenges of MedTech companies. Hansjörg Riedwyl has also recently authored the “Guideline for app developers, manufacturers and distributors: Overview of key terminology and processes for definition, development and marketing of an app as a medical device” (PDF) for eHealth Suisse.

About the Lecture

Digital health interventions offer a lot of new opportunities for all involved stakeholders. For example, healthy individuals, patients, health care providers such as physicians or patient organizations can potentially use and offer novel healthcare self-services. But there are also hurdles to be considered. That is, digital health interventions can become medical devices as per medical device regulations and these regulations are dramatically changing. It is therefore crucial for managers and developers to understand the borderline between a Software as Medical Device (SaMD) and a “normal” software application. This guest lecture will focus on this complex topic.

You are invited to join this guest lecture by

Prof. Dr. Tobias Kowatsch, Assistant Professor for Digital Health, University of St.Gallen (HSG) Scientific Director, Center for Digital Health Interventions (CDHI), ETH Zurich & HSG

Prof. Dr. Elgar Fleisch, Professor of Technology Management, HSG Professor of Information Management, ETH Zurich Advisory Board Member, CDHI

Prof. Dr. Florian von Wangenheim, Professor of Technology Marketing, ETH Zurich Advisory Board Member, CDHI Registration is not required.