3 ECTS credits
90 h study time
Offer 1 with catalog number 4024454DNR for all students in the 2nd semester at a (D) Master - preliminary level.
This course provides an introduction to the European medical device legislation for both medical devices and in vitro diagnostics, to equip students with the knowledge and skills necessary to navigate the complex regulatory landscape governing medical devices in Europe. The course will also touch upon the basics of United States regulations (FDA). Particular attention will be paid to device qualification and classification, risk management, general safety and performance requirements, and quality management according to ISO 13485 standards, in particular activities such as design and development, including usability, and verification and (limited) validation.
Didactic techniques: lectures, self-study, tasks, discussion groups
Starting competencies: Students should have a bachelor degree in Engineering, Physics, Law, Industrial design
Final competences
Understanding of the key regulatory frameworks governing medical devices at national and international levels, in particular the European Union.
Ability to interpret and apply the European medical device legislation to ensure compliance in the development, manufacturing and marketing of devices.
Ability to create and evaluate technical documentation required for regulatory submissions, including the application of design controls, verification and validation, risk management, and labeling.
Understanding the framework of a Quality Management System (QMS) according to regulatory requirements, ensuring adherence to Good Manufacturing Practices (GMP) and ISO 13485
The final grade is composed based on the following categories:
Oral Exam determines 70% of the final mark.
Practical Exam determines 30% of the final mark.
Within the Oral Exam category, the following assignments need to be completed:
Within the Practical Exam category, the following assignments need to be completed:
Open book exam
This offer is part of the following study plans:
Master of Biomedical Engineering: Startplan
Master of Biomedical Engineering: Profile Radiation Physics
Master of Biomedical Engineering: Profile Biomechanics and Biomaterials
Master of Biomedical Engineering: Profile Sensors and Medical Devices
Master of Biomedical Engineering: Profile Neuro-Engineering
Master of Biomedical Engineering: Standaard traject (NIEUW)
Master of Biomedical Engineering: Profile Artificial intelligence and Digital Health