A17. TGA Reforms and implications for Medical Device Sponsors
Tracks
Medical Devices Regulation Summit
Tuesday, June 3, 2025 |
2:45 PM - 3:45 PM |
Chair & Speakers
Jean Boudaud
Director, Medtech Services APAC
PharmaLex Pty Ltd
TGA Reforms and implications for Medical Device Sponsors
Biography
Jean brings 18+ years of industry experience in Project Management, Quality Assurance and Regulatory Affairs primarily gathered in the Medical Device/IVD industry.
He has significant experience in Management Consulting and leads PharmaLex's APAC Medtech Services.
He puts into practice his strong technical background and hands-on expertise to provide practical solutions to the challenges faced by his clients in any phase of their product lifecycle.
He focuses on implementing strategies that meet business requirements and bring efficiencies, whilst meeting the strict regulatory obligations of our industry.
Jean is a Certified Engineer from France and holds a Master’s Degree of Engineering (Mechanical). He received ASQ Certification for Auditing in 2013 and is bilingual in French and English.
Xin-Lin Goh
Director
TGA, Devices Reforms Taskforce within the Medical Devices and Product Quality Division
TGA Reforms and implications for Medical Device Sponsors
Biography
Nehzat Hazratian
Arthrex
TGA Reforms and implications for Medical Device Sponsors
Biography
Jenny Lin
Senior Manager, Medical Devices/IVD
PharmaLex Pty Ltd
TGA Reforms and implications for Medical Device Sponsors
Biography
