AI, Regulatory Affairs & Transformation in Medical Technology (MBA)

The MBA programme in “AI, Regulatory Affairs & Transformation in Medical Technology (MBA)” at Dresden International University (DIU) combines artificial intelligence, digital medical technologies, regulatory affairs, quality management, and leadership. It is designed for experienced professionals who want to understand, evaluate, and shape AI-enabled transformation in healthcare and medical technology under real regulatory conditions. The programme provides advanced theoretical and practice-oriented competencies to assess digital healthcare systems, manage AI-enabled medical device development, understand regulatory frameworks such as MDR, IVDR, and the EU AI Act, and lead transformation processes in complex healthcare environments. Please note: A positive accreditation report has been issued, and applications are already being accepted. The Accreditation Council will grant accreditation in September 2026. Programme structure The AI, Regulatory Affairs & Transformation in Medical Technology MBA is structured as a modular part-time degree programme. The curriculum combines scientific research and leadership with healthcare technology, medical technology development, regulatory affairs, and AI-enabled transformation. Students develop the strategic, analytical, regulatory, and technological skills needed to evaluate innovations and lead transformation processes across healthcare and the MedTech sector. The programme covers areas such as scientific research, leadership in digital healthcare, healthcare delivery models, medical technology development, medical device regulation, and the digital transformation of healthcare, product development, and regulatory processes. Students also gain essential competencies in data, artificial intelligence, cybersecurity, interoperability, health IT systems, quality management, and risk assessment. A particular focus is placed on connecting technological innovation with regulatory requirements and organisational implementation. Practice-oriented assignments, case studies, and interdisciplinary exchange prepare students to manage AI-enabled medical technologies throughout their life cycle and take on strategic leadership roles in healthcare, medical technology, regulatory affairs, quality management, and digital transformation. Study schedule Classes on-site and online: three online sessions per month and nine consecutive days on-site in Dresden Language of instruction: English Additional components: scientific working, empirical research, statistics, leadership development, and team competence

Course details verified 10 Sep 2026 — intakes, entry requirements and course facts · official source

1. Winter semester

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Prerequisites

Already possesses a college or university degree (equivalent to 240 credit points) recognised in the country of origin AND Can demonstrate at least one year of qualified practical professional experience in industry AND Experiences in AI and digital products or processes and digitalisation AND Proof of advanced knowledge of English

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