Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

Standalone Modules

Module 7 - Clinical Evaluation for Medical Devices

Content

Module 7 concentrates on the clinical evaluation required to demonstrate the device’s intended purpose without exposing users and patients to unnecessary risk. The module covers the collection and reporting of pre- and post-market clinical data including safety reporting.

We will add more information about this module soon. If you are interested to learn specific information in the meantime, please contact us.

Start & Duration

Module 7 starts in September each year.
The completion takes approximately 6 weeks.

Credits

4 ECTS

Fee

The cost of this standalone module is 4'200.– SFr.

Reference

03.007

Module Leaders

CEO MD-CLINICALS SA and Founder of the World Medical Device Organization

Danielle Giroud

With over 30 years of experience, Danielle Giroud is an internationally recognized clinical research and regulatory expert within the global medical device industry. She has shared her extensive knowledge and experience with multi-national companies, organizations, and start-ups from around the world to help bring their products to market quickly and efficiently.