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MedTech Summit

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10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)

Rikke Lewinsky
Senior Clinical Surveillance Scientist at Radiometer Medical
Speaker

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

  • Decoding Periodic Safety Update Reports (PSURs) and Summary of Safety and Clinical Performances (SSCPs)

    14:30