Meeting room VIA

As part of your technical file required for your European CE Marking/ conformity assessment process, you have to create and maintain a Clinical Evaluation Report.

If you are a startup company, this seminar is very important as you need to create a clinical evaluation plan and also perform a state-of-the-art literature search at an early stage.

Please join us when we dive into this topic and what it means and entails for you, as an inventor and manufacturer of a medical device. We will have the expert from TUV SUD from Germany giving us the expert’s view including the impact of the new medical device regulation as well as introduce you to a company that will share their experience in the daunting task in creating the technical file for the first time!

Program:

08:30     Welcome, by Norway Health Tech (Anita)

08:40     TUV SUD – “Clinical Evaluation Report – The most important document in your technical file” by Dr. med. habil. René Bombien

09:20     User case: As a new startup and little knowledge in the regulatory field – the technical file requirements overwhelmed. What did we do and what did we learn? by RemovAid – dr Marte Bratlie (CEO)

09:40     Summary, Questions

10:00     Possibility for 1:1 meetings with  TUV SUD and LINK Medical, please book when registering

WELCOME!!