Technology Track G: Quality Focus – Medical Device Life Cycle Risk Management
September 26, 2024 AM | Meeting Room A, Hall 1, Shanghai World Expo Exhibition & Convention Center, Shanghai, China
Background:
On December 14, 2023, the National Medical Products Administration (NMPA) revised the Code of Practice for the Quality Management of Medical Device Businesses, which will came into force on July 1, 2024. The continuous revision and optimization of the quality management standard highlights the importance that the state attaches to quality management. The frequent FDA recalls in the first half of the year also served as a wake-up call to major companies that improving quality management is a top priority. The quality system and process are essential for outputting a better product; It is also what we have learned from the bitter lessons year after year, as well as a cornerstone of a long-lasting business.
This forum will focus on the techniques and methods of quality control in the manufacturing process and clinical testing of medical devices, and is dedicated to providing enterprises with inspirations to cope with various quality inspections and improve their competitiveness.
Participants:
- Medical device manufacturers: heads of departments of manufacturing, technology, quality R&D, as well as project/company leaders
- The enterprises engaged in medical device regulatory and quality consulting, research and services.
- Medical device quality regulatory agencies and others
Agenda:
Time |
Agenda |
9:50-10:00 |
Moderator Remarks |
10:00-10:30 |
Testing and Management in the Process of Medical Device Manufacturing |
10:30-11:00 |
Active Device Detection and Scope of Application (FFR) |
11:00-11:30 |
Sensors in Inspection 1: Distance Measuring Sensors Boosts Standard Design of Medical Devices |
11:30-12:00 |
Sensors in Inspection 2: Use of Pressure Sensors in Mechanical Performance Testing |
12:00-12:10 |
Conference Close |
*The agenda may be subject to changes due to adjustment of confirmed speakers