Course Description
This course provides information on The New MDR regarding clinical trials for Medical Devices in Europe. In this course, you will discover new definitions and types of trials as well as the main actors involved, specifically sponsor, investigator and subject. You will also learn about conditions, ethical principles, methods and the informed consent process and develop a better understanding of the new coordinated assessment. This course also provides information regarding substantial changes, temporary halt, and termination as well as adverse event reporting. After each course, you can take a brief test to receive your certification!