中国国际医疗器械设计与制造技术展览会(Medtec China)2018

Dedicated to design & manufacturing for medical device

25-27 September 2019 | Shanghai,China

Quality Track A: Risk Management of Medical Product Life Cycle

Introduction

Agenda

Speaker

Sponsor/Package

Registration

Transportation

Medtec China 2019: MDiT Forum and Regulation Summit 2019

Quality Track A: Risk Management of Medical Product Life Cycle

Morning of Sep 26, 2019 | Conference Room X, B2 of SWEECC

Organizer: Medtec China

 

Introduction  

 

Conference Background

  • Risk management, which is running through the whole medical product life cycle, has become the basic requirement in QMS and medical device regulations. ISO 13485-2016 version and the latest EU-MDR also emphasize the importance of risk management. Besides, risk management is very important for medial device design and development, manufacture, and post-market, which contributes to reduce listing time and increase competitiveness.
  • After much discussion, it was decided that the international standard ISO 14971:2007 would be revised. It is expected that the revised international standard will be adopted as a European Standard, and changes will be implemented in the first or second quarter of 2019.
  • Hot topics for quality standard and techniques will be selected for Quality Trach each year in Medtec China, not only the latest information for QMS regulation and standard, practice experience will be sharing in the track.

Conference Content

  • Updates and orientation of ISO 14971
  • Biological evaluation and testing of medical device based on risk management
  • Risk management in the process of medial device design and R&D
  • Replying post-market supervision by adopting risk management in product life cycle

 Who Should Attend?

  • Manufacturing, Technology, QC/QA, R&D and Risk Management Department, Project Manager/Director and Managing Director from medical device manufacturers
  • Regulation and Quality Service Suppliers and Consulting
  • Surveillance Organization and Other Organization

*Conference agenda updates according to speaker confirming.

Agenda  

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Speaker  

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Sponsor/Package

>> Sponsor Package

Registration 

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Transportation 

Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai

Hotel Reservation 

Speech & Cooperation

Carina Li

T:+86-10-5730 6163

E:carina.li@ubm.com

Sponsor & Paid Conference

Julia Zhu

+86-21 6157 3922

E:julia.zhu@ubm.com

Media & Free Conference

Sophia XU

T:+86-10-5730 6095

E:Sophia.xu@ubm.com