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 4, B2 of SWEECC

Organizer: Medtec China

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
• From the Perspective of Device Manufacturer: How to Conduct Reliability-Centered Medical Device Quality Management
• Development Status and Analysis of Medical Device Reliability

 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.

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• Carrie Wu, Quality Director; M.R., Conod Medical Co., Limited
• Chunren Wang, Director, Research Fellow, Office of Biological Materials, NIFDC
• Lingyun Shao, Deputy Director, Central R&D Management Department (Reliability & Product Safety & Public Platform), Mindray Bio-Medical Electronics Co., LTD
• Chunxia Li, Director, Laboratory of Medical Equipment Reliability, Institute of Integrated economy and Technology of Mechanical Industry Instrument

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Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai

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