Medical Device Regulation

Upon completion of the course, the student will be able to: - Define classes of a medical device - Manage the concepts and processes of medical device regulation

Medical Device Regulation (3 ECTS), timetable for autumn 2022: Session 1 - Compliance as a business advantage 22/09/2022, at 10.00-12.30 EET Session 2 - Early Development and Management 27/09/2022, at 10.00-12.30 EET Session 3 - The Core of Regulatory Requirements 29/09/2022, at 10.00-12.30 EET Session 4 - Design Control and the Regulatory Environment 04/10/2022, at 10.00-12.30 EET Session 5 - In Vitro Diagnostics 06/10/2022, at 10.00-12.30 EET Session 6 - Medical Device Software 11/10/2022, at 10.00-12.30 EET Session 7 - FDA 13/10/2022, at 10.00-12.30 EET Session 8 - Risk Management in Practice 01/11/2022, at 10.00-12.30 EET Session 9 - Usability and Labelling 03/11/2022, at 10.00-12.30 EET Session 10 - Biological and Electromedical Safety 08/11/2022, at 10.00-12.30 EET Session 11 - Clinical Evaluation in Practice 10/11/2022, at 10.00-12.30 EET Session 12 - Clinical Investigations in Practice 15/11/2022, at 10.00-12.30 EET Session 13 - Post-Market Surveillance and Clinical Follow-up 17/11/2022, at 10.00-12.30 EET Session 14 - Person Responsible for Regulatory Compliance 22/11/2022, at 10.00-12.30 EET Note! The lecture recordings will be available after the lectures, and the course can be completed until 31.3.2023.

Final exam