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

Author: Huiyu GUAN ¹ ; Fang XU ¹ ; Haitao FU ² ; Ting WANG ¹ ; Cong ZHANG ¹ ; Liang HUANG ¹ ; Wei YUAN ¹ ; Wendi ZHU ¹
Author Information

1. Center for Evaluation and Inspection of Hubei Drug Administration, Wuhan, 430071.
2. Hubei Medical Device Quality Supervision and Inspection Institute, Wuhan, 430075.
Publication Type:Journal Article
Keywords: after registration; design and development changes; laser treatment equipment; research; risk control
MeSH: Humans; Laser Therapy; instrumentation; Risk Factors
From: Chinese Journal of Medical Instrumentation 2020;44(4):346-352
CountryChina
Language:Chinese
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.