HKSTP

[Template] Regulatory Workshop -Road to Europe and Beyond: Mastering EU Regulatory & Market Entry Challenges for Medical Devices & IVDs

MFR 1, 2/F, Inno2, 17W號大樓

Event Date/Time:

This session will feature industry experts sharing practical insights on navigating the EU regulatory framework, ensuring compliance with quality management systems, and overcoming market access challenges. Case studies will highlight successful strategies for certification, clinical evidence, and commercialization.

Speakers include:
Don Lee - Deputy Director, Business Development, Business Assurance, SGS Hong Kong Limited
Gene Tang - Co‑Founder & General Manager, MediConcepts Limited

Mr. Michal Pallo – CEO, GATE-U Limited