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MedTech Summit
Hybrid Event, 20 - 24 June 2022
In-Person: Clayton Hotel Burlington Road, Dublin, IrelandDigital Experience: One track will be live-streamed each day in BST time zone, with on-demand recording access for all other tracks made available from the afternoon of the following day. Learn more on the Digital Experience page.

Rikke Lewinsky
Senior Clinical Surveillance Scientist at Radiometer Medical

Profile

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.

Agenda Sessions

  • Industry Case Study: Building a Periodic Safety Update Report for Devices and Diagnostics

    10:10