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20-04-2026

The number and complexity of regulatory requirements (laws, directives, regulations, standards, guidelines etc.) is exploding. Both, domain specific requirements such as the EU Medical Device Regulation, as well as orthogonal requirements such as the EU AI Act are a burden for most manufacturers. The talk provides a comprehensive overview of the regulatory landscape specifically for CDSS and gives guidance how to avoid the typical pitfalls and to reach regulatory compliance effectively and efficiently.

Prof. Dr. Christian Johner - Johner Institute

Professor Johner is a leading expert in the development and approval of medical devices, particularly those incorporating or consisting of software. Through his diverse roles as an auditor, standards committee member, policy advisor, trainer of notified bodies, and author of numerous books and guidelines, Dr. Johner actively contributes to the advancement of regulatory frameworks and the digital transformation within the medical device ecosystem. His company, the Johner Institute, offers comprehensive services to the medical device industry worldwide. These include regulatory guidance, device testing, professional training through seminars and e-learning courses, and support for digital transformation initiatives. The Institute also provides Enterprise SaaS solutions to streamline regulatory processes for manufacturers, authorities, and notified bodies. Throughout his career, Christian has shared his expertise through teaching engagements at several institutions, including the University of Konstanz (Germany), the University of St. Gallen (Switzerland), the University of Würzburg (Germany), and Stanford University (USA).

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