You have a solution (e.g. surgical tool, vascular implant, equipment or material for in vitro diagnostics, software etc.) which may become a medical device?
In this online SPARK Europe Webinar Series, Dr. Jani Virtanen is giving insightful information on getting regulatory approval needed to launch your medical device to the market. You may implement this knowledge in constructing your research plan and planning budget for your next grant application.
After this talk, you will:
- understand the right order of main steps to get CE approval needed for your medical device to launch on the EU market
- get an overview on timelines and the budget needed for the approval process
- know the requirements for selecting a suitable Notified Body
- understand when to choose US market as your first regulatory approval territory
Dr. Jani Virtanen has been working in several international medical device companies (e.g. Nexstim, Sooma Oy, GE Healthcare) for 17 years and has brought more than 15 medical devices to the market. He holds a PhD in Medical Engineering from University of Oulu.
The Webinar will be hosted by SPARK Finland.
Online via Zoom | Please register here!
Registration to the webinar is required in advance. Please register no later than 6 November 2023. Please note that you will receive the Zoom link and access code the evening before the lecture and that access to last minute registrations, cannot be guaranteed.
SPARK Europe is the joint network of SPARK sites all over Europe including Israel: SPARK-BIH, SPARK Finland, SPARK FLI, SPARK Norway, SPARK Poland, SPARK Tel Aviv, SPARK Denmark and SPARK Zürich. European SPARK programs are members of SPARK Global network. The purpose of SPARK programs is to provide the education and mentorship necessary to advance research discoveries from the bench to the bedside, hence to increase the maturity of academic and clinical discoveries towards practical solutions that address unmet needs in the life science and health tech space. The program follows the same principles that have been the cornerstones of SPARK at Stanford since it was established by Professor Daria Mochly-Rosen and Kevin Grimes in 2006 for advancing new biomedical research discoveries into promising new treatments for patients.
