Rules & Regulations for Designing Medical Devices

This master elective course provides insights into the medical design directives regarding safety of healthcare products by focusing on the CE marking process (including ISO norms and risk management). The course includes several lectures of TU Delft researchers and external professionals working in the healthcare field. Next to the lectures, students will do several duo-assignments in which they apply insights into practice with the use of a case-study. The course shows students the importance of risk analysis of healthcare products and helps them to integrate this in their design process.