| 关于医疗器械企业实施过程确认的几点看法 |
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| 引用本文： | 王慧芳. 关于医疗器械企业实施过程确认的几点看法[J]. 中国医疗器械信息, 2012, 18(5): 1-4 |
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| 作者姓名： | 王慧芳 |
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| 作者单位： | 北京国医械华光认证有限公司,北京,100011 |
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| 摘 要： | 关于医疗器械特别是使用时须无菌和植入的医疗器械,其生产中有不少过程需要实施确认,在<医疗器械生产质量管理规范(试行)>及相应的细则中对此也提出了明确的要求.然而,很多企业的过程确认是比较薄弱的,甚至是没做过程确认就开始批量生产.为了给企业一个抛砖引玉的参考,本文就如何实施过程确认谈谈个人的看法,仅供沟通交流.
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| 关 键 词： | 医疗器械 过程确认 |
Some Views about Process Validation for Medical Devices Production |
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| WANG Hui-fang. Some Views about Process Validation for Medical Devices Production[J]. China Medical Devices Information, 2012, 18(5): 1-4 |
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| Authors: | WANG Hui-fang |
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| Affiliation: | WANG Hui-fang Beijing Huaguang Certification of Medical Devices Co.,Ltd(Beijing 100011) |
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| Abstract: | Many processes should be validated for medical device production,Process validation is required in Medical Device Quality Management System Regulation(QMSR) issued by SFDA.But many medical device manufactures don’t understand and know how to do process validation.In this text,the writer presents Some Views about Process Validation for Medical Devices Production. |
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| Keywords: | medical device process validation |
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