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

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

Planned launch October 2026 / Pre-accreditation phase

The MBA in AI, Regulatory Affairs & Transformation in Medical Technology at Dresden International University invites innovators, clinicians and tech strategists to one place where cutting‑edge artificial intelligence meets the strict realities of European medical‑device law. In four flexible semesters you will decode the EU AI Act, MDR and IVDR, design data‑driven care solutions and sharpen the leadership mindset that tomorrow’s med‑tech market demands.

This MBA enables you to develop a critical and forward-looking perspective on how digital technologies are currently deployed in healthcare, why limitations exist, and how to shape realistic yet positive strategies for tomorrow’s digitalisation. You will gain a deep understanding of today’s regulatory frameworks—how they apply in practice, how they are evolving, and how agile and intelligent approaches can make regulation more efficient. Above all, the programme develops you into a leader of digital transformation, able to align real healthcare needs with future product and service innovation, and to drive regulatory and quality strategies that truly improve patient outcomes and healthcare system performance.

Our degree program is designed for:

• Ambitious professionals aiming to step into strategic leadership roles in digital health, AI, and regulatory affairs.
  
• Managers and experts who want to shape the future of healthcare through innovation, digital transformation, and smart technologies.
  
• Professionals in the medical technology, healthcare delivery, and pharmaceutical sectors, including product development, quality, regulatory, compliance, legal, and health technology assessment.
  
• Advisors, consultants, and specialists working with notified bodies, authorities, or healthcare systems.
  
• Innovators with experience in AI and digitalization – from developing AI-enabled medical devices to applying generative AI and LLMs in healthcare processes.
  
• Also suitable for career changers with relevant experience aiming to enter the medtech sector.
  
  

Admission Requirements

• 1+ experience in industry
  
• Minimum: bachelor or equivalent
  
• Knowledge of English on at least B2 level (CEFR)
  
• Experience in AI and digital products or processes and digitalization need to be listed in the motivation letter and proofed by work references
  
• Additional interviews may be necessary if there is a lack of language skills or questions arise regarding the application documents. These will be arranged on an individual basis
  
  

Further Information.