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.
Partner Institution
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.
Overview of the study contents
Module 0 – Compulsory module (5 ECTS)
Develop essential academic skills in scientific working. Learn to structure and write a term paper on a self-chosen topic according to academic standards, and present key findings clearly and effectively within a set timeframe.
Module 1 - Current models of technology in healthcare delivery (5 ECTS)
Prof. Dr. Stephen Gilbert
Understand the organisation, workflows, and digitalisation of EU healthcare systems. Explore key technologies like EHRs, telemedicine, AI, and wearables, along with barriers to adoption and integration challenges.
Module 2 - Current models of medical technology development (5 ECTS)
Prof. Dr. Stephen Gilbert
Examine innovation processes from research to market adoption. Learn how quality management, regulation, and commercialization influence success or failure of devices, including software and digital therapeutics.
Module 3 - Current medical device regulatory processes (5 ECTS)
Prof. Dr. Stephen Gilbert
Gain in-depth knowledge of EU MDR, IVDR, and the AI Act, as well as FDA and global regulations. Critically assess their role in safety, competitiveness, and the challenges of implementing digitalisation.
Module 4 - Managing digital and AI-enabled transformation in healthcare delivery (5 ECTS)
Prof. Dr. Stephen Gilbert
Explore how telemedicine, predictive analytics, LLMs, and AI-assisted diagnostics are transforming care. Assess opportunities, risks, and oversight models for safe, effective, and holistic healthcare delivery.
Module 5 - Managing digital and AI-enabled transformation of medical technology development (5 ECTS)
Prof. Dr. Stephen Gilbert
Analyze how AI drives innovation in device design, testing, and post-market surveillance. Explore real-world cases of AI-assisted development and low-code/no-code tools in medical device creation.
Module 6 - Managing digital and AI-enabled transformation of medical device regulatory processes (5 ECTS)
Prof. Dr. Stephen Gilbert
Investigate how AI and digital tools reshape regulatory submissions, compliance, and safety monitoring. Learn how data-driven systems enable more efficient and transparent regulatory decision-making.
Module 7 - Technology competencies for leaders in future healthcare (5 ECTS)
Prof. Dr. Stephen Gilbert
Build essential skills in data literacy, digital integration, cybersecurity, and ethical AI use. Develop the technical knowledge needed for strategic leadership in healthcare digital transformation.
Module 8 - New skillsets for leadership in digital healthcare delivery and digital medical product development (5 ECTS)
Prof. Dr. Stephen Gilbert
Develop modern leadership skills to navigate the VUCA world. Learn digital change management, communication, team and conflict resolution, and corporate digital responsibility.
Module 9 - Master's Thesis (15 ECTS)
Prof. Dr. Stephen Gilbert
Apply acquired skills in an independent research project. Develop scientifically grounded solutions to real-world digital health challenges, combining academic rigor with practical relevance.
Scientific Director
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
Overview
Degree:
Master of Business Administration (MBA)
Location:
Partly Onsite in Dresden & Online
Start:
Planned launch October 2026
Pre-accreditation phaseDuration:
4 Semester
Language:
English
Credit points:
60 ECTS
Study type:
Part-time
Tuition Fees:
As the MBA is currently in planning, tuition fees are not yet finalized. Interested candidates will be the first to receive updates once details are available.
