| 医疗器械的全寿命质量与安全监管模式探讨 |
| |
| 引用本文： | 喻洪流,钱省三. 医疗器械的全寿命质量与安全监管模式探讨[J]. 中国医疗器械杂志, 2006, 30(2): 120-123 |
| |
| 作者姓名： | 喻洪流 钱省三 |
| |
| 作者单位： | 1. 上海理工大学医疗器械学院/上海医疗器械高等专科学校,上海,200093
2. 上海理工大学管理学院,上海,200093 |
| |
| 基金项目： | 上海市重点学科建设项目 |
| |
| 摘 要： | 分析了一种基于政府主体的医疗器械全寿命质量与安全监管概念．并针对医疗器械的特点．讨论了在此模式下的医疗器械的寿命周期模型及其对应的监管方法，在此基础上．探讨了一种基于全寿命监管体制下我国医疗机构医疗器械应用质量与安全保证的政府监管模式。
|
| 关 键 词： | 医疗器械 全寿命 质量与安全 监管 |
| 文章编号： | 1671-7104(2006)02-0120-03 |
| 修稿时间： | 2005-05-19 |
Exploration on the Regulation Mode of Medical Device Quality and Safety on a Life-Circle Basis |
| |
| YU Hong-liu,QIAN Xing-san. Exploration on the Regulation Mode of Medical Device Quality and Safety on a Life-Circle Basis[J]. Chinese journal of medical instrumentation, 2006, 30(2): 120-123 |
| |
| Authors: | YU Hong-liu QIAN Xing-san |
| |
| Affiliation: | University of Shanghai for Science and Technology, Shanghai 200093. |
| |
| Abstract: | A new conception of the life-circle state regulation for medical device's quality and safety is analyzed in the paper. The life-circle model and its corresponding regulation methods are discussed according to the characteristics of medical devices. Then, the regulation mode for application quality and safety of medical devices in a life-circle regulation system is explored. |
| |
| Keywords: | medical device life-circle quality and safety regulation |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ |
