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 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?
Programme
In this SPARK Europe event, Anne-Mari Håkelien and Ingvild Gudim will provide some answers and perspectives to these questions, covering both MDR and IVDR.
Anne-Mari Håkelien
Anne-Mari is a Senior Adviser 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 Gudim
Ingvild is a Senior Adviser 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.