How to manage regulatory affairs for health startups
- hosted by SUND Hub
In this session, you will get an insight into the regulatory affairs relating to the development and launch of products and services which are used to diagnose, prevent, relieve or treat a disease, disability or injury.
The session will provide you with a fundamental understanding of WHEN, HOW and WHY to
- Apply for CE-mark
- Set-up your Quality Management System and
- Conduct your first clinical trials – all in accordance with the EU and FDA regulations.
The details will be updated in the end of august.
Who can join:
Teams and startups from SUND Hub have priority. Others can register if spots are available.
Registration is mandatory
Please register before November 25th as we have limited spots because of the covid-19.