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.
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