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中国医疗器械杂志 2020, Vol. 44 Issue (4) :346-351    DOI: 10.3969/j.issn.1671-7104.2020.04.015
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对激光治疗设备注册后升级设计开发更改的风险控制的研究
官辉煜1,许芳1,傅海涛2,王婷1,张聪1,黄亮1,袁炜1,朱文迪1
1 湖北省药品监督管理局技术审评核查中心,武汉市,430071
2 湖北省医疗器械质量监督检验研究院,武汉市,430075
Research on Risk Control of Upgraded Design and Development Changes of Laser Treatment Equipment after Registration
GUAN Huiyu1, XU Fang1, FU Haitao2, WANG Ting1, ZHANG Cong1, HUANG Liang1, YUAN Wei1, ZHU Wendi1
1 Center for Evaluation and Inspection of Hubei Drug Administration, Wuhan, 430071
2 Hubei Medical Device Quality Supervision and Inspection Institute, Wuhan, 430075

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摘要 对激光治疗设备常见设计开发更改成因及更改风险进行分析,研究关键元器件的更改及其应对控制措施, 形成对激光治疗设备设计更改的识别方法,并对设计开发更改如何处置给出了建议,以供检查员现场检查 时参考。
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关键词激光治疗设备   注册后   设计开发更改   风险控制   研究     
Abstract: This paper analyzes the causes and risks of common design and development changes of laser treatment equipment, studies the changes of key components and their corresponding control measures, forms the identification method of design changes of laser treatment equipment, and gives suggestions on how to deal with design and development changes, so as to provide references for inspectors during on-site inspection.
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Received 2019-08-28;
About author: 官辉煜,E-mail: guanhuiyu@163.com
引用本文:   
官辉煜1,许芳1,傅海涛2,王婷1,张聪1,黄亮1,袁炜1,朱文迪1.对激光治疗设备注册后升级设计开发更改的风险控制的研究[J]  中国医疗器械杂志, 2020,V44(4): 346-351
GUAN Huiyu1, XU Fang1, FU Haitao2, WANG Ting1, ZHANG Cong1, HUANG Liang1, YUAN Wei1,.Research on Risk Control of Upgraded Design and Development Changes of Laser Treatment Equipment after Registration[J]  Chinese Journal of Medical Instrumentation, 2020,V44(4): 346-351
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