Tag: clinical
The guidelines for clinical exams
Die In ISO 14155: 2000 It is a standard with the title that has not been harmonized so far for the MDR “Clinical investigations on medical devices for human subjects – good clinical practice”. In German: “Clinical examination of medical devices – good clinical practice”. He then describes the state of the art for producers…
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Clinical validation vs. clinical evaluation
The term clinical validation it is also often used in relation to medical devices. For example, the BMBF publishes a guideline on the topic “Clinical validation of innovative medical technological solutions”. The FDA also talks about it clinical validation. What is clinical validation? How does it differ from a clinical evaluation and a clinical trial?…
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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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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…
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