Dr. Anja Kuhnert

Medical Writer: What this role must accomplish

By Dr. Anja Kuhnert December 16, 2024 Leave a comment

Medical writers have a firm place in the ecosystem of medical device and IVD manufacturers. This article clarifies 1. Summary A medical writer is a person who collects and evaluates research results and information on the use of products and medical information in the field of pharmaceutical and medical device research and documents them in…

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SSCP – Avoid redundant work on the “Summary of Safety and Clinical Performance”

By Dr. Anja Kuhnert September 23, 2024 1 Comment

The SSCP (Summary of Safety and Clinical Performance) is not the only report that the MDR requires from many medical device manufacturers. In terms of content, the SSCP even overlaps with the PSUR and the PMS reports. The IVDR places almost identical requirements on the SSP (Summary of Safety and Performance). How do all these…

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