After taking this course participants should be able to:

• Guarantee the safety and efficiency of medical technology developments and their application

• Apply in-depth knowledge of laws and regulations regarding medical devices

• Recognize and assess risks related to the development and use of Medical Devices

• Propose design improvements for safety

• Establish the safe and effective introduction of medical devices into a hospital

Week 1: Medical Devices Regulation

Introduction, definitions, classes of devices, overview of CE conformity procedures.

Week 2: Development of Medical Devices

CE conformity procedures in detail, Annex I, based on example device(s).

Week 3: Risk Analysis

ISO14971, ISO TR 24971, link to TU Delft’s Forensic Engineering method (as taught in the MOOC Forensic Engineering).

Week 4: Clinical Research

Art. 82 etc., Annex XIV & XV, ethical standards.

Week 5: Introduction and Implementation of Medical Devices in the Clinic

“Convenant Veilige Toepassing van Medische Hulpmiddelen” as example, selecting and introducing medical devices into the hospital, maintenance, repairs, in-house developments, custom devices.

Week 6: Final Assignment and Wrap-up

Choose from three devices: classify it and perform brief risk analysis, answer law-related questions, and take part in design improvement quizzes.