Course aims, objectives and structure 课程目标、学习目的和课程架构

Risk management: Terms and definitions 风险管理：术语和定义

茶歇

Risk management and the Quality Management System (QMS)

风险管理和质c

Risk management and the Medical Device Regulation (MDR)/In Vitro Diagnostic Regulation (IVDR)

风险管理和医疗器械法规(MDR)和体外诊断法规(IVDR)

午餐

ISO 14971:2019 New Revision Change ISO 14971:2019 新版的变化

茶歇

ISO 14971:2019: General structure 通用结构

Annexes and ISO/TR 24971 附录和ISO/TR 24971

ISO 14971:2019: Application of risk management to medical devices

ISO 14971:2019医疗器械风险管理应用

• Scope 范围

• General requirements for risk management systems 风险管理体系通用要求

• Risk management process 风险管理过程

Day 2

内容

• Risk analysis 风险分析

茶歇

• Risk evaluation 风险评价

• Risk control 风险控制

午餐

• Evaluation of overall residual risk 综合剩余风险评价

• Risk management review 风险管理评审

• Production and post-production activities 生产和生产后活动

茶歇

Risk Management Technique: FMEA Requirement

风险管理技术：新FMEA 基本要求

Risk Management Audit Requirement & Most Frequent Mistakes

风险管理审核要求和最常见错误