Meet & Greet with Gert Bos in Shanghai, China

June 21, 2017 / China

Event information

Gert will be leading the Fundaments Training of the New Medical Device Regulation (MDR)

- 欧盟医疗器械新法规培训.

开课日期Training Dates: 21-23 June 2017

课时Duration: 2.5天 (2.5 days)

6月21日 (21 June) 9:00-17:00 
6月22日 (22 June) 9:00-17:00 
6月23日 (23 June) 9:00-12:00

上海 (酒店信息报名后通知)
Shanghai (Hotel information to be informed after registration)


培训费用 Registration Fee: ¥6,000 RMB


课程目标 Learning Objectives:
On completion of the training, participants will be able to:
• 理解欧盟医疗器械合规路径 Understand the Medical Device Regulations approach in Europe
• 理解医疗器械法规的框架及其目的 Understand the structure and purpose of Medical Device Regulation
• 解释基本原则的使用,包括(协调)标准和通用规范 Explain the use of Essential principles including the use of (harmonized) standards and Common Specifications
• 应用新的分类标准和执行原则 Apply the new Classification Criteria and Implementation rules
• 识别新的符合性审核路径 Identify the new conformity assessment routes
• 识别修改过的技术文件要求 Identify revised Technical Documentation requirements
•临床数据的重要性及其角色 Importance and role of Clinical Data
•识别上市后监督的重要性和内容 Identify the importance and contents of Post Market Surveillance

课程大纲 Program Overview:

•医疗器械法规及新方法 Medical Device Regulation and the New Approach
•法规和操作结构 Legal and operational structure
•医疗器械法规的框架和目的 Structure and purpose of MDR EU 2017/745
•医疗器械法规的通用内容 General Contents of MDR EU 2017/745
•新合规审核路径 New conformity assessment routes
•基本原则 Essential Principles
•风险管理的角色及其重要性 Role and importance of Risk Management
•主动上市后监督及临床跟踪 Active Post Market Surveillance & PMCF
•警戒系统及向主管当局报告要求的修改 Revisions to Vigilance and reporting to the Competent Authority
•临床评价及临床实验 Clinical Evaluation & Clinical Investigation
•问答 Questions & Answers
•课程评估及总结 Evaluation of the Course and Closing

培训对象 Who should attend:
•高级管理者 Senior Management
•质量和法规经理 Quality Managers and Regulatory Affairs Managers
• 临床事务经理 Clinical Affairs Manager
• 产品开发经理 Design & development Managers
•生产经理 Manufacturing managers
•海外市场经理 Oversea Market Managers

培训语言Training Language:
英文讲解及中文总结/重点翻译 English presentation & Summary/Highlight Chinese translation
资料发放Training Material:
不发放打印件, 使用电子教材; E-copy Training Material instead of Hardcopy.

For more details, please contact:

报名联系人Registration Contact: 陈明华 女士 Mrs. Minghua Chen
联系手机Mobile: 18061661543



More information about Gert Bos and Minghua Chen:

Gert W. Bos
Minghua Chen
Post date: June 02, 2017
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