医疗器械临床评估_中英文翻译.docVIP

CLINICAL EVALUATION REPORT 临床评估报告 For Product: XXXX 产品：XXXX Document No. XXXXXXXX 文件编号 Version: 1.0 版本: Date: 2015-11-24 日期: Author: 作者: Reviewed by: 审阅: Approved by: 批准: Company 公司 Table of Content 目录 Page页码 1. General details总述 3 2. Description of the device and its intended application器械描述和预期用途 3 3. Intended therapeutic and/or diagnostic indications and claims 预期治疗和/或诊断说明和要求 3 4. Context of the evaluation and choice of clinical data types 评估背景和临床数据类型的选择 3 5. Summary of the clinical data and appraisal总结临床数据和评价 4 6. Data analysis数据分析 5 6.1. Performance性能 5 6.2.