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

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

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。

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.