Current Models of Medical Technology Development
In the individually bookable course “Current Models of Medical Technology Development” at Dresden International University, you will explore how innovative medical technologies progress from research and product design to clinical validation, regulatory approval, and practical use in healthcare. The module focuses on digital, data-driven, and AI-enabled technologies, including their development, safety requirements, and integration into clinical practice.
You will examine technologies ranging from software as a medical device and AI-supported diagnostics to advanced clinical systems such as robotic surgery and proton therapy. The course connects technical innovation with quality management, risk assessment, reimbursement, and regulatory considerations, helping you better understand the full development pathway of modern medical technologies.
Individually bookable module of the MBA degree program
This course corresponds to Module 3 of the “AI, Regulatory Affairs & Transformation in Medical Technology (MBA)” degree program. It can be booked independently without enrolling in the full MBA program. If you later decide to pursue the MBA, the recognition of previously completed coursework and credit points is subject to an individual academic review and the applicable examination regulations.
Key Facts
Qualification
5 ECTS credits
upon successful completion of the module examCourse start
6 April 2027
Duration
1 Semester
Course location
On-site, DIU-Campus Dresden;
Online
Course format
Hybrid: synchronous and asynchronous study
Credit points
5 ECTS
Language
English
Course fee
€1,668
Our professional development program is designed for:
- Medical technology and product development professionals who want to deepen their understanding of innovative medical devices, their development processes, and pathways to clinical application.
- Regulatory affairs and quality management specialists seeking to connect technical innovation with regulatory requirements, product safety, and risk management.
- Digital health and AI professionals working with software as a medical device, AI-enabled diagnostics, remote monitoring, or other emerging healthcare technologies.
- Healthcare managers and clinical innovation specialists involved in evaluating, implementing, or managing new medical technologies within healthcare organizations.
- Engineers and clinical scientists interested in the relationship between technological development, clinical evidence, usability, and healthcare delivery.
Lecturer
Rebecca Mathias (M.Sc.)
Regulatory Affairs Professional Society (RAPS)
Content & Qualifications
Course content
The module covers key stages and considerations in modern medical technology development, from initial research concepts to clinical implementation.
- Medical technology development: research concepts, product design, clinical validation, regulatory approval, reimbursement, and adoption in healthcare systems.
- Digital and AI-enabled medical technologies: software as a medical device, AI-supported diagnostics, disease management applications, remote monitoring, wearables, and digital health tools.
- Complex clinical systems: proton therapy, MR-linac systems, AI-supported clinical decision-making, and the implementation of safety-critical technologies in hospitals.
- Quality management and human factors: usability, product safety, clinical effectiveness, risk assessment, and relevant quality management frameworks.
- Emerging technologies: brain–computer interfaces, AI-assisted robotic surgery, agentic medical AI models, and hospital-at-home care.
- Technology integration: interoperability, digital health ecosystems, clinical workflows, and the interaction between technical, regulatory, economic, and organizational requirements.
What you will learn
After completing the course, you will be able to:
- explain the main stages of medical technology development, from early research and design to clinical application,
- assess digital and AI-enabled medical technologies in terms of their potential clinical benefits, risks, and practical usability,
- distinguish development and regulatory considerations for technologies with different levels of complexity and risk,
- evaluate the role of quality management, human factors, and clinical validation in medical device development,
- analyze how reimbursement, healthcare infrastructure, and regulatory requirements influence the adoption of innovative technologies, and
- connect technical development decisions with clinical workflows and broader healthcare systems.
Examination and Credit Points
The module concludes with a portfolio examination consisting of a written description and an interactive presentation. Each component accounts for 50% of the overall examination grade. Participants receive 5 ECTS credit points upon successfully passing the module examination.
Admission Requirements
The course can be booked as an individual module without enrolling in the full MBA degree program. Participation is subject to the applicable admission requirements and examination regulations. The DIU Study Advisory team can help clarify your eligibility based on your academic background and professional experience. Please include information about your educational qualifications and professional background when submitting your course registration inquiry.
Personal advice
Frequently Asked Questions
Can I enroll in this course without joining the full MBA program?
Yes. The course is an individually bookable module from the degree program “AI, Regulatory Affairs & Transformation in Medical Technology (MBA)” You can request enrollment in this module without applying for the full MBA, provided you meet the applicable admission requirements.
Request course registration now
What topics are covered in the course?
The course explores medical technology development from research and product design to clinical use. Topics include AI-enabled medical devices, digital health applications, clinical validation, quality and risk management, advanced medical technologies, and regulatory considerations.
Is the course offered online or on campus?
The course follows a hybrid learning format combining online learning with on-site activities at the DIU Campus in Dresden. It includes synchronous and asynchronous learning components. Detailed dates and scheduling information are available upon request.
How many ECTS credits can I earn?
You can earn 5 ECTS credits by successfully completing the module examination, which consists of a written description and an interactive presentation. Both components contribute equally to the final grade.
Can the module be recognized toward the MBA degree later?
Recognition of previously completed modules is subject to the applicable academic regulations and an individual review by DIU. The Study Advisory team can explain the requirements if you are considering the full MBA at a later stage.