MDR: The Role of Regulatory Affairs in Clinical Trials

The clinical evidence of your medical device is crucial. Gain knowledge, network and discuss perspectives on the topic.

For a medical device the clinical evidence is essential and before you plan a clinical investigation you should know your device and the competition on the market.

A good clinical evaluation will provide you with the knowledge needed to limit the scope of potential clinical investigations, formulate a clinical strategy, and set up a roadmap to market – including future development of your product. Starting this work early on will save you time and money.

This track also includes perspectives on AI and Article 5.5.

Program

13:30 – 13:40 Welcome and introduction to the program
Marlene Højstrup Jensen, Community Manager, Danish Life Science Cluster

13:40 – 14:05 Presentation: The Role of Clinical Trials in Regulatory Affairs
Maria Lindgren, Director Clinical Strategy, Key2Compliance

14:05 – 14:30 Questions and discussion

14:30 – 14:45 Break & network

14:45 – 15:45 Workshop (get to know each other)

15:45 – 16:00 Round-up

16: 00 Thank you for today