Turnus of offer:
every summer semester
Course of studies, specific field and terms:
- Master Medical Informatics 2019 (optional subject), interdisciplinary competence, 1st or 2nd semester
- Master Interdisciplinary Courses (optional subject), Interdisciplinary modules, Arbitrary semester
Classes and lectures:
- ME4520-V: Introduction to Medical Device Regulation (lecture, 2 SWS)
- ME4520-S: Introduction to Medical Device Regulation (seminar, 1 SWS)
- ME4520-Ü: Introduction to Medical Device Regulation (exercise, 1 SWS)
- 60 Hours in-classroom work
- 60 Hours work on an individual topic with written and oral presentation
Contents of teaching:
- Regulatory framework for the marketing of medical devices in the EU
- Requirements for manufacturers of medical devices
- Quality management for medical device manufacturers
- Application of risk management to medical devices
- Application of usability to medical devices
- Clinical evaluation of medical devices
- Students describe the regulatory framework for the marketing of medical devices in the EU.
- They explain the concepts of regulatory requirements in the development, production, marketing, distribution, operation, maintenance and market surveillance of medical devices.
- They recognize and justify which requirements are relevant for a product.
- They apply norms and standards specifically to comply with requirements.
- They are proficient in risk analysis and assessment methods.
- They use elements of the usability-oriented development process.
- They assess the quality of a clinical evaluation.
- They compile contents of the technical documentation.
Responsible for this module:
Prerequisites for attending the module:
Prerequisites for the exam:
ME4520-L1: Portfolio Exam Introduction to Medical Device Regulation with a total of 100 points, divided as follows:
- 70 points for active participation in the classroom sessions and group work, submission of homework assignments
- 20 points for elaboration and presentations
- 10 points for an e-test
The module focuses on medical device law from the perspective of manufacturers and developers of medical devices. However, the module is not only aimed at future technical developers of medical devices but at all those who can contribute to the design of medical devices in interdisciplinary teams.
A maximum of 40 students can participate in one semester.
Letzte Änderung: 1.4.2021