3 ECTS credits
90 u studietijd
Aanbieding 1 met studiegidsnummer 4024454DNR voor alle studenten in het 2e semester met een inleidend master niveau.
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
De beoordeling bestaat uit volgende opdrachtcategorieën:
Examen Mondeling bepaalt 70% van het eindcijfer
Examen Praktijk bepaalt 30% van het eindcijfer
Binnen de categorie Examen Mondeling dient men volgende opdrachten af te werken:
Binnen de categorie Examen Praktijk dient men volgende opdrachten af te werken:
Open book exam
Deze aanbieding maakt deel uit van de volgende studieplannen:
Master of Biomedical Engineering: Startplan (enkel aangeboden in het Engels)
Master of Biomedical Engineering: Profiel Radiation Physics (enkel aangeboden in het Engels)
Master of Biomedical Engineering: Profiel Biomechanics and Biomaterials (enkel aangeboden in het Engels)
Master of Biomedical Engineering: Profiel Sensors and Medical Devices (enkel aangeboden in het Engels)
Master of Biomedical Engineering: Profiel Neuro-Engineering (enkel aangeboden in het Engels)
Master of Biomedical Engineering: Standaard traject (NIEUW) (enkel aangeboden in het Engels)
Master of Biomedical Engineering: Profiel Artificial intelligence and Digital Health (enkel aangeboden in het Engels)