Research on Risk Control of Upgraded Design and Development Changes of Laser Treatment Equipment after Registration / 中国医疗器械杂志

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.