Technology Track G: Quality Focus – Medical Device Life Cycle Risk Management
Co-organizers: Medtec China
Introduction
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.
Agenda
September 26, 2024 AM | Meeting Room A, Hall 1, Shanghai World Expo Exhibition & Convention Center, Shanghai, China
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
LCDR Scott C. Gonzalez,FDA International Program and Policy Analyst – Medical Devices,China Office
Zeli Yu,RAC GLOBAL
Speech & Cooperation
Rebecca Lv
T: +86-21 6157 7279
Sponsor & Paid Conference
Lorelei Yu
+86-21-61573861
Media & Free Conference
Carina Li
T:+86 10 6562 3307
Co-organizers:Medtec China
Conference 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.
Who Should Attend?
Agenda
September 26, 2024 AM | Meeting Room A, Hall 1, Shanghai World Expo Exhibition & Convention Center, Shanghai, China
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
Speaker
LCDR Scott C. Gonzalez,FDA International Program and Policy Analyst – Medical Devices,China Office
Zeli Yu,RAC GLOBAL
Sponsor/Package
Registration
Travel Service
Speech & Cooperation
Rebecca Lv
T: +86-21 6157 7279
Sponsor & Paid Conference
Lorelei Yu
+86-21-61573861
Media & Free Conference
Carina Li
T:+86 10 6562 3307
Organizer:
Organizer
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