Rikke Lewinsky

Senior Clinical Surveillance Scientist at Radiometer Medical

Speaker

I am a Senior Clinical Surveillance Scientist with Radiometer Medical.

Radiometer Medical is a global medical device and IVD company that provides powerful acute care diagnostic solutions. In the department of Clinical Surveillance I am responsible for collecting post-market data and writing Periodic Safety Update Reports as well as performing clinical evaluations/performance evaluations.

In the past two years I have worked on setting up a solid post-market surveillance process in Radiometer and at the same time contributed to the technical files submission ensuring our continued compliance with EU requirements.

I hold a PhD in molecular biology and worked as Post. Doc. for a number of years before making a career move towards the industry. I have more than 10 years’ experience in post-market surveillance in both drug and device industry as well as expertise in understanding the new regulations on medical device and IVD. I am passionate about improving the post-market surveillance system for the benefit of users, patients and us as manufacturer.