European Medical Devices Regulation: Practical Application

This module introduces the fundamentals of Medical Devices Regulation, covering key definitions, device classifications, and an overview of CE conformity procedures. It provides a foundation for understanding the regulatory landscape in the medical device industry.

This module delves deeper into CE conformity procedures, with a focus on Annex I requirements. It uses example devices to illustrate the practical application of these procedures in medical device development.

This module covers risk analysis in medical device development, focusing on ISO14971 and ISO TR 24971 standards. It also introduces TU Delft's Forensic Engineering method, linking it to risk analysis practices in the medical device field.

This module explores clinical research in the context of medical devices, covering Article 82 and Annexes XIV & XV of the Medical Devices Regulation. It also addresses ethical standards in clinical research for medical devices.

This module focuses on the practical aspects of introducing and implementing medical devices in clinical settings. It covers topics such as device selection, maintenance, repairs, in-house developments, and custom devices, using the "Convenant Veilige Toepassing van Medische Hulpmiddelen" as an example.

This module serves as a comprehensive assessment of the course material. Participants will choose from three devices to classify and perform a brief risk analysis, answer law-related questions, and participate in design improvement quizzes. This practical application of knowledge reinforces the learning outcomes of the course.