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Technology Track G: Quality Focus – Medical Device Life Cycle Risk Management

Technology Track G: Quality Focus – Medical Device Life Cycle Risk Management

MDiT Forum and Regulation Summit 2024—— Technology Track G: Quality Focus – Medical Device Life Cycle Risk Management

Co-organizers: Medtec China

Introduction

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:

  • 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

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 

Transportation 

Speech & Cooperation

Rebecca Lv

T: +86-21 6157 7279

E:Rebecca.lv@informa.com

Sponsor & Paid Conference

Lorelei Yu

+86-21-61573861

E:Lorelei.Yu@informa.com

Media & Free Conference

Carina Li

T:+86 10 6562 3307

E:Carina.li@informa.com

MDiT Forum and Regulation Summit 2024—— Technology Track G: Quality Focus – Medical Device Life Cycle Risk Management

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?
  • 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

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

E:Rebecca.lv@informa.com

Sponsor & Paid Conference

Lorelei Yu

+86-21-61573861

E:Lorelei.Yu@informa.com

Media & Free Conference

Carina Li

T:+86 10 6562 3307

E:Carina.li@informa.com