Guan Huiyu, Xu Fang, Fu Haitao, Wang Ting, Zhang Cong, Huang Liang, Yuan Wei, Zhu Wendi. Research on Risk Control of Upgraded Design and Development Changes of Laser Treatment Equipment after Registration[J]. Chinese Journal of Medical Instrumentation, 2020, 44(4): 346-352. DOI: 10.3969/j.issn.1671-7104.2020.04.015
      Citation: Guan Huiyu, Xu Fang, Fu Haitao, Wang Ting, Zhang Cong, Huang Liang, Yuan Wei, Zhu Wendi. Research on Risk Control of Upgraded Design and Development Changes of Laser Treatment Equipment after Registration[J]. Chinese Journal of Medical Instrumentation, 2020, 44(4): 346-352. DOI: 10.3969/j.issn.1671-7104.2020.04.015

      Research on Risk Control of Upgraded Design and Development Changes of Laser Treatment Equipment after Registration

      • 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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