BSI专家受邀出席第五届医疗器械监督管理国际论坛(CIMDR)

Speaker
演讲人

Topic
主题

Sub-forum
分论坛

Time
时间

Gert W. Bos

Top non-conformities in CAPA for MD manufacturers – EU vs FDA requirements
医疗器械制造商纠正预防措施 中常见的不符合项 – 欧盟和美国要求对比

Medical device Innovative technology and Product Forum
医疗器械创新技术与产品论坛

Aug.28 09:25- 10:00

Gert W. Bos

New UDI guidance from Europe
欧洲新的唯一器械标识指南

UDI/GMDN Forum
唯一器械标识与全球医疗器械命名法论坛

Aug.28 15:00- 15:40

Gert W. Bos

Understanding clinical equivalence in EU
EU临床等效性解读

Medical Device Clinical Trial Forum
医疗器械临床试验 论坛

Aug.28 15:50- 16:20

Gert W. Bos

The Importance Role of Regulatory Professional– Challenges and Opportunities (European)

RAPS论坛

Aug.28 16:40- 17:00

Liang Qian
钱亮

Review of 3D printing and customized orthopedic products - a notarized body perspective
从公告机构的角度谈3D打印和定制化骨科产品审核思路

Orthopaedics and Surgical Devices Forum
骨科及手术器械论坛

Aug 29
09:15-09:45

Liang Qian
钱亮

Orthopedics devices review & Top Non-conformities for CE Marking
欧盟 CE认证过程中齿科产品审核及常见问题

Odontological Devices Forum
齿科器械论坛

Aug.28 17:35- 18:05

Lane Ji
计利方

Administration and Quality Supervision of the Medical Devices in Use
医疗器械使用中的管理和质量监督

Medical Imaging Devices Forum
医用影像类器械论坛

Aug 28 16:00- 16:40

Lane Ji
计利方

Global Regulatory Requirement for eHealth
移动医疗——医疗器械的法规要求

Operation Room, Amubulance and Physiotherapy Equipment Forum
手术室、救护及理疗器械论坛

Aug 28 14:25- 15:00

Lane Ji
计利方

the introduction of new version of ISO 13485:201X
新版ISO 13485:201X简介

Medical Imaging Devices Forum
医用影像类器械论坛

Aug 29 09:40- 10:10

Yun Sun
孙芸

The Impact of Changing Medical Device European Regulatory Requirements
欧洲医疗器械法规要求变化的影响

In-vitro Diagnostic Devices Forum体外诊断试剂论坛

Aug 28 16:30- 17:00