Basic training on Medical Device Regulation

Our basic course on clinical studies under the Medical Device Regulation (MDR) is suitable for researchers, freelancers and sponsor / CRO personnel involved in clinical trials with medical devices in Europe, who need to know what has changed since the MDR is in force.

The course consists of 6 modules:

• Module 1: The Basics
• Module 2: Scope of the MDR
• Module 3: Submitting clinical studies
• Module 4: Safety Reporting and Modifications
• Module 5: Post-Marketing Clinical Follow-Up
• Module 6: Vigilance Reporting

NOTE: This course does not cover the local laws and regulations that apply to medical device research in specific European Member states!

eLearning on smartphone, tablet or PC in self-selected stages!

Our interactive course can be started, interrupted and resumed anytime, anywhere. Learn at your own pace! Please note that this e-learning is only available in English.

The modular structure and the associated division into content chapters enable an individual learning experience.

Who is this course for?

• For researchers in the field of medical devices
• For employees of sponsors, CROs or freelancers