Medical device compliance is imperative to the success of every medical device company. Failing to achieve compliance will compromise the future of the product.
It is in everyone’s best interest to produce quality medical devices, therefore this industry is heavily regulated.
But, how do you actually achieve compliance for your medical device?
In this SPARK Europe Webinar, Anne-Mari Håkelien & Ingvild Gudim will provide some answers and perspectives to these questions, covering both MDR and IVDR.
Anne-Mari is a Senior Advisor at The Norwegian Medicines Agency with an extensive experience from both regulatory authorities and basic cancer research. She has also worked in a cell therapy start-up. Anne-Mari holds a PhD in molecular biology from the University of Oslo.
Ingvild is a Senior Advisor for medical devices and IVD medical devices at The Norwegian Medicines Agency. Prior to that she was working several years as project leader and technical lead for diagnostic immunoassay development in Gentian Diagnostics ASA. Ingvild holds a PhD in biochemistry from the University of Oslo.
Online via Zoom ǀ Please register here!
Registration to the webinar is required in advance. Please register no later than May 3rd 2022.
The webinar will be hosted by SPARK Norway.
SPARK Europe is the joint network of SPARK sites all over Europe including Israel: SPARK-BIH, SPARK Finland, SPARK FLI, SPARK Norway, SPARK Poland and SPARK Tel Aviv. 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.
