眼科激光光凝机的风险分析及现场核查关注点概述

Overview:Risk Analysis&On-Site Inspection of Ophthalmic Laser Photocoagulation Machine

医疗器械技术审评与注册质量管理体系核查是医疗器械上市前安全有效性评价非常重要的两个环节,两者结合能够较好地分析医疗器械产品的风险。本文将技术审评与现场核查的关注点结合,从眼科激光光凝机类医疗器械技术特点及生产工艺出发,结合技术审评关注点开展风险分析,探索性提出了此类产品现场体现检查的一些建议,供生产企业的质量管理人员及医疗器械检查员参考。

Technical evaluations on medical devices and inspections on registration quality management systems are two core tasks for the safety and effectiveness evaluation of medical device registration.The combination of the two tasks will lead to a better analysis on risks of medical devices.In this article,the main concerns on the technical review and on-site inspection of medical devices were taken into consideration,and certain explorative suggestions on the on-site inspection of medical devices were raised to provide references for quality control staff of medical device manufacturers and medical device inspectors based on an overall consideration of the technical characteristics and production process of ophthalmic laser photocoagulation and a risk analysis on the concerns of technical inspection on such medical devices.