AI, Regulatory Affairs & Transformation in Medical Technology: Course Overview

The MBA degree program “AI, Regulatory Affairs & Transformation in Medical Technology” at Dresden International University (DIU) brings together artificial intelligence, digital medical technologies, regulatory affairs, and transformation leadership in one part-time Master’s program.

Designed for experienced professionals in healthcare, MedTech, regulatory affairs, quality management, product development, compliance, and digital transformation, the program provides a structured learning journey across the full lifecycle of AI-enabled medical technologies.

Participants gain a practical understanding of healthcare systems, medical technology development, regulatory frameworks, AI-supported transformation, and leadership in complex healthcare environments. The curriculum connects academic depth with real-world application and prepares professionals to shape digital and regulatory innovation responsibly.

A positive accreditation report has been issued, and applications are already being accepted. The Accreditation Council will grant accreditation in September 2026.

The individually bookable modules from “AI, Regulatory Affairs & Transformation in Medical Technology (MBA)” allow you to build focused expertise in selected areas of AI-enabled healthcare, medical technology development, regulatory affairs, quality management, and digital transformation.

This option is suitable if you want to deepen your knowledge in a specific subject area without enrolling in the full MBA degree program immediately. You can choose the module that matches your professional role, current responsibilities, or future development goals.

Depending on your selection, you will work with topics such as digital healthcare systems, software as a medical device, AI-enabled medical devices, digital clinical studies, quality management systems, post-market surveillance, regulatory processes, health IT systems, and transformation management.

The modules are designed for professionals from healthcare, MedTech, regulatory affairs, quality management, compliance, product development, consulting, and digital innovation. They support you in assessing AI-enabled technologies in relation to safety, performance, clinical integration, evidence generation, ethics, quality systems, reimbursement, and regulatory approval.

Before booking, you can receive personal advice from the DIU Study Advisory team to clarify which module best fits your goals and what your next step could be.

• already posses 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 digitalization AND
• proof of advanced knowledge of English on the TOEFL level 570, iBT79 or IELTS 6.0 or similar knowledge

Please submit the following documents as part of your application:

• Curriculum Vitae (CV)
• High school diploma / proof of university entrance qualification
• Diploma(s) from previous academic programs, including transcript of records
• Proof of English language proficiency according to the general English language proficiency requirements
• Additional program-specific documents
  • Proof of at least one year of qualified practical professional experience in industry
  • Proof or description of experience with AI, digital products, digital processes or digitalization
• Optional motivation letter specifying your experience with AI, digital products, digital processes or digitalization

Please use our official application form 

Send your complete application materials to studyadvisory@di-uni.de.