Is my software a medical device? How to step forward?

In this online SPARK Europe Webinar Series, Heikki Pitkänen will discuss the regulatory landscape of medical software solutions.



After this talk, you will have an understanding on what the rules are and how challenging it is to define which software is or is not regulated by the MDR or the IVDR in EU. We will discuss what are the grounds to classify software into Class IIa or higher, exposing them to Notified Body assessment, or in Class I in remote cases. We'll make a brief comparison to the US FDA and what the regulations mean in practice for medical device software developers, not forgetting AI. For the knowledge transfer, Heikki will use their proprietary regtech platform Entries to explain some of the above principles.

Online via Zoom| Please register here!

Registration to the webinar is required in advance. Please register no later than 9 April 2024. 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, SPARK Zürich and SPARK at the Faculty of Medicine, Masaryk University. 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.


SPARK-BIH is a member of the SPARK Global network