HEALTH INNOVATORS: How to navigate in regulatory affairs in health startups?

- hosted by SUND Hub

In this sesseion we dive into how to navigate in regulatory affairs in health startups?

When developing new solutions that can cure or diagnose, you must be aware of the regulations - the earlier the better! So even though you are still an early stage entrepreneur, your entrepreneurial journey in the health care sector will take you on the path of regulatory affairs along the way. The earlier you gain insight in what needs to be done, the easier the path will be when developing your solutions. 

For example, medical devices must be CE marked before they can be placed on the market. Other solutions such as measurement, system and treatment packages as well as equipment for clinical testing do not require CE marking. However, such products may be required to obtain other forms of certification or to meet specific marking requirements. 

In this session we guide you towards a basic understanding and set you up with our experts in the field of: 

  • CE marks
  • Clinical trials
  • Documentation

PROGRAM:

  • 14:00: Welcome & Who is in the room (Elevatorpitch from all start-up’s). 
  • 14:20: Setting your strategy for regulatory navigation for medical devices w. Claus Rømer
  • 14:40: Quality Management Systems w. Kenn Milton
  • 15:00: Conducting clinical trials w. Paul Hargreaves 
  • 15:20: BREAK
  • 15.30: Intro to break out sessions: select two rounds of break out sessions with the speakers 
    • 15:30: Break-out session #1
  • 16:00: Break 
    • 16:10: Break-out session #2 
  • 16:40: Wrap-up
  • 17:00: Thank you for today

Who can join:
Teams and startups from SUND HubSCIENCE Innovation Hub and Human & Legal Innovation hub have priority. Other students can register to get inspiration for future projects in the hubs. Others can register if spots are available.

Registration is mandatory: 
Register here

Deadline:
2021.04.05