Tag: clinical
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…
Read More
A valuable tool for research in clinical literature
«Go later PICO scheme This is the recommendation of many reviewers and reviewers, as well as some regulatory documents (such as the MDCG and MEDDEV 2.7/1 rev.4 guidelines) when it comes to precise searches of medical literature. Read in this article, what is PICO scheme and what variations you should know, in which tasks (even…
Read More