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MDiT Forum and Regulation Summit 2020

Quality Track A: Practice of Risk Management of Medical Product Life Cycle

Afternoon of Sep 15 | Conference Room 3

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. 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.
• Are your product risk management documents laid up? In this session we will discuss better practices for leveraging risk management throughout the product lifecycle, from concept to end of product life. It will show you how risk management be implemented from design and manufacturing to post-marketing surveillance to ensure product safety and support risk-based decision making. Risk management can lower costs, improve quality and shorten the lead time. Please make good use of your risk management documents and benefit from them.
• 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

• 1,How to use ISO13482:2016 risk management files in the entire medical product life cycle
• 2,How to reduce budget with risk management-manufacturer perspective
• 3.Integrate Risk Management in post-market surveilance activity practised on Active Medical Device
• 4,How to integrate different regulations/standards to establish a quality system for preclinical research and meet the requirements of global regulatory agencies

 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.

>> Download the agenda of MEDTEC China 2020

Diana Hong,President,Mid-Link Biomedical Technology Group, Guest Professor, NMPA Institute of Executive Development；Secretary General, Third-party Testing Association of China Association of Medical Device Industry Guest Professor, Science Faculty of Shanghai University

Tamara Yuan, V.P., Quality Assurance, APAC Operations, Zimmer Biomet Inc

Shumei Wang,Vice President, Head Office of Quality Management and Regulatory Affairs of UNITED IMAGING

Millie Chen, PhD; Deputy GM, Medical device testing, WuXi AppTec

Complete guest Introduction Download

>> Sponsor Package

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Conference Room of Shanghai World Expo Exhibition & Convention Center

North Entrance, No. 850 Bocheng Rd. Shanghai

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