2025 APEC Foundational Principles of Medical Device Clinical Evidence and Risk Management

Day 1 | Focus on Clinical Assessments
Date and Time | Nov. 3 (U.S.) 3:00 PM – 8:00 PM PT
Nov. 4 7:00 AM – 12:00 PM Taipei (+1),
8:00 AM – 1:00 PM Seoul (+1) Learn about clinical evidence for devices, definitions and key concepts, clinical investigations, clinical evaluations, and clinical evidence for in vitro diagnostic devices (IVDs)

Day 2 | Optimizing Risk and Safety of Devices
Date and Time | Nov. 4 (U.S.) 3:00 PM – 8:00 PM PT
Nov. 5 (Asia) 7:00 AM – 12:00 PM Taipei (+1),
8:00 AM – 1:00 PM Seoul (+1) Learn about GHTF/IMDRF guidelines, adverse event reporting, ISO 14971:2019, IVDs, post-market surveillance, and pre-market risk evaluation tools