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

MDiT Forum and Regulation Summit 2020

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

Morning of Sep 15, 2020 | Conference Room , 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. 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,How to combine risk mangement with design、lable、complainment and post sales supervision of vitual medical device
4,Tips of Improving risk management files to support the quality control based on data driven

Who Should Attend?

Manufacturing, Technology, QC/QA, R&D and Risk Management Department, Project Manager/Director and Managing Director from medical device manufacturers