Join our IVDR Transition Period Extension – Breathing Room Amidst Persistent Challenges webinar and learn what the IVDR transition extension means for manufacturers, the key compliance challenges ahead, and practical steps to navigate the evolving regulatory landscape with confidence.
- Date: 26th June
- Time: 11:30-12:30 CET
Speakers:
- Samuel BUET – Medical Device Consultant Manager at Strategiqual, a ProductLife Group company, specializing in medical device regulatory affairs and quality systems. His professional experience includes regulatory strategy development (EU, FDA), technical documentation preparation, and quality system implementation for medical devices and IVDs. Previous roles include Regulatory Affairs Manager at Mayoly Spindler Diagnostics and Product Manager at Takara Bio Europe. His work spans global market access, MDR/IVDR compliance, and quality process optimization.
- Quentin NONGLATON – Medical Device and IVD Consultant Manager. He specializes in quality assurance and regulatory affairs for medical technologies, with expertise spanning medical devices (MD) and in vitro diagnostics (IVD). Professionally, he has held regulatory and quality roles at Hologic, Mobidiag, and currently serves as MD/IVD Consultant Manager at Strategiqual, a ProductLife Group entity. His experience covers regulatory compliance, quality systems implementation, and risk management for medical technologies.
- Thierry SIRDEY – Innovation and Operational Team Lead. He currently serves as Team Lead for Innovation and Operational Excellence at ProductLife Group. With over 25 years of experience in medical technology regulation, he previously held key leadership roles at ANSM (French National Agency for Medicines and Health Products Safety), including Head of Division for Medical Devices and IVDs, where he oversaw market surveillance, clinical trials authorization, and European regulatory affairs. His career spans medical device development (Hutchinson Santé), regulatory enforcement, and innovation pathways. His expertise covers the full product lifecycle from R&D to post-market surveillance in both national and European regulatory frameworks.
