A declaration of interest is a formal document designed to make potential conflicts of interest transparent. Individuals submit a declaration of interest to demonstrate their objectivity and independence. This article is about declarations of interest in a clinical context.
DetailsMedical 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…
DetailsThe 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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