时间

主题

9:00~10:00

课程目标、学习目的和课程架构

Course aims, objectives and structure

10:00~11:00

医疗器械行业风险管理的发展

Development of risk management in the medical device industry

11:00~12:00

讲解ISO14971标准新版的变化趋势

Explain the changing trend of the new version of ISO14971   standard

13:00~14:00

风险管理：术语和定义

Risk management: Terms and definitions

14:00~15:00

风险管理过程的策划  

Planning of risk management process

15:00~17:00

风险识别、分析、评价的方法和工具，   如FTA、FMEA等。

Methods and tools for risk identification, analysis and   evaluation, e.g. FTA, FMEA

DAY 2

时间

主题

9:00~11:00

风险控制包括：分类、处置、变更等风险管理的讲解

Risk management explanation   of risk control includes: classification, disposal, changing 

11:00~12:00

剩余风险、综合剩余风险的讲解

Explanation of residual risk and overall residual risk

13:00~14:00

风险评估报告的管理，包括整理报告、更新报告。

Risk assessment report   management, including compile reports, update reports, etc.

14:00~15:00

医疗器械生产及生产后信息的跟踪。

Follow up the production and post-production information

15:00~16:30

ISO13485标准中相应的风险管理要求与ISO14971标准的对应关系。

Correspondence between ISO   13485:2016 and ISO 14971:2019

16:30~17:00

通过练习、考试等方式对学员学习效果进行考评。

The learning effect is evaluated by exercises and examinations.