浅析远程视频检查在医疗器械注册质量管理体系核查中的应用

Analysis of the Application of Remote Video Inspection in the Quality Management System Verification of Medical Device Registration

在新冠疫情的影响下,远程视频检查成为医疗器械注册质量管理体系核查的重要方法之一。本文对医疗器械注册质量管理体系核查远程视频检查进行研究,分析远程检查的优势,剖析医疗器械注册质量管理体系核查环节应用远程视频检查的必然性,同时提出了远程视频检查的实施建议,包括设施设备要求和工作流程等,以期提升远程视频检查医疗器械注册质量管理体系工作效率和监管能力,为科学决策检查工作提供参考。

Under the influence of the COVID-19 pandemic,remote video inspection has become a crucial method for examining the quality management systems in medical device registration.This article conducts research on remote video inspection of medical device registration in the quality management system,analyzes the advantages of remote inspection,and explores the inevitability of applying remote video inspection in the verification process of medical device registration in the quality management system.It also provides implementation recommendations for remote inspection,including facility and equipment requirements,and workflow,aiming to improve the efficiency and regulatory ability.This work serves as a reference for scientific decision-making and inspection work.