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[医疗器械临床评价实践]

[Practice of Medical Device Clinical Evaluation].

作者信息

Lyu Hongguang

机构信息

Shanghai NQA Certification Co., Ltd, Shanghai, 200122.

Acea Bio(HangZhou) Co., Ltd, Hangzhou, 310030.

出版信息

Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Jul 30;42(4):305-308. doi: 10.3969/j.issn.1671-7104.2018.04.022.

DOI:10.3969/j.issn.1671-7104.2018.04.022
PMID:30112903
Abstract

For medical device clinical evaluation activities, reference to international and domestic medical device regulations and guidance documents, this paper briefly introduces the implementation steps of clinical evaluation of medical devices, and focus on the evaluation report should be included in the content, provides reference for relevant personnel of medical devices registration and certification on medical device clinical evaluation practice.

摘要

对于医疗器械临床评价活动，参考国际和国内医疗器械法规及指导文件，本文简要介绍了医疗器械临床评价的实施步骤，并重点阐述了评价报告应包含的内容，为医疗器械注册和认证相关人员在医疗器械临床评价实践方面提供参考。

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