The responsible use of artificial intelligence in medical technology requires much more than technological expertise. Regulatory requirements from the MDR, IVDR and the EU AI Act as well as challenges along the entire product life cycle are increasingly shaping the industry. Dresden International University (DIU) is responding to this with a new part-time MBA program “AI, Regulatory Affairs & Transformation in Medical Technology”.

The course is intended to qualify professionals who combine AI and digital health skills with regulatory know-how, quality management, clinical evidence and strategic leadership. It is aimed at experts from medical technology companies, healthcare organizations and the field of digital health who want to responsibly develop, approve and integrate AI-supported medical devices into care.

Scientific Director Prof. Dr. Stephen Gilbert from the Else Kröner Fresenius Center for Digital Health at the Technical University of Dresden contributes his expertise in Medical Device Regulatory Science. The course covers the entire product life cycle from development, approval and quality management to post-market surveillance and integration into clinical processes.

The MBA starts in October 2026, lasts four semesters and is offered part-time. The courses will take place mostly online, supplemented by eight attendance days per semester in Dresden. The degree is a Master of Business Administration with 60 ECTS credits.

The development of the degree programme is taking place against the background of a growing need for interdisciplinary skills. AI-powered medical devices are already a regulatory reality, but many systems are dynamically changing due to updates and real-world usage data. This requires new approaches to regulation that combine innovation with patient safety and transparency.

The program is designed to fill a gap by combining technical understanding, regulatory intelligence, and responsible leadership. It is responding to the increasing complexity in the development and market launch of AI-based medical devices in Europe.

Editor: X-Press Journalistenbüro GbR

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