Conducting Medical Device Clinical Investigations in Switzerland

This course provides a comprehensive overview of the Swiss regulatory and ethical requirements for conducting clinical investigations with medical devices in the pre-and post-market phases.
This course covers the following topics:
Members of the Swiss Competent Authority (Swissmedic) and Swiss Ethics Committees
Laws concerning medical devices and clinical investigations with medical devices, including references to the applicable guidance documents, templates, and forms
Notification requirements of Swissmedic and Swiss Ethics Committees
Safety reporting requirements during clinical investigations
Other reporting requirements during clinical investigations and close-outs
Clinical trial insurance requirements
Data protection requirements
Learn more at: wmdo.org/cours...