Tag: Summary
STED (Summary Technical Documentation) and ToC (Table of Contents): how useful is it
It’s the STED (Summary Technical Documentation) and their successors ToC (summary) the solution for medical device manufacturers who need to have their products approved internationally? This article presents the STED or ToC and therefore a suggestion on how manufacturers can structure the technical documentation. 1. STED: a brief introduction a) Why STED/ToC can be useful…
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SSCP Safety and Clinical Performance Summary
Die SSCP (“Summary of Safety and Clinical Performance”) is not the only relationship that the MDR required by many medical device manufacturers. The content of the SSCP even overlaps with the PSUR and PMS report. Die IVDR presents with that SSP (“Safety and Performance Summary”) almost identical requirements. How do all these relationships differ from…
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