Quality Track A: Risk Management of Medical Product Life Cycle

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

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