Boutrand J P
Biomatech SAS, a Namsa Company, Chasse sur Rhône, France.
Med Device Technol. 2004 Oct;15(8):28-31.
A clinical trial is designed to provide clinical evidence of compliance with the medical device Directives. Clinical evidence can also be based on systematic and objective literature review. This article highlights when to use the clinical or the literature route to demonstrate the safety and performance of a medical device.
临床试验旨在提供符合医疗器械指令的临床证据。临床证据也可基于系统和客观的文献综述。本文重点介绍何时采用临床途径或文献途径来证明医疗器械的安全性和性能。
