Based on your feedback, we’re focusing on practical approaches to device risk management. Expect expert-led interactive group activities, topics include:
- IMDRF and GHTF Guidelines: Exploring Their Role in Risk Management
- Using Environmental and Human Factors to Reduce Device Risk: Case Studies
- Insights into Pre-market Risk Evaluation Tools: Clinical Evaluation Report (CER)
- Post-approval Risk Management: Insights from Post-Market Surveillance Report (PMSR) and Periodic Safety Update Report (PSUR)
- Enhancing Device Safety through ISO 14971:2019 and Risk Management Applications
- Special Risk Considerations for In vitro Diagnostic Devices
Don’t miss out on our lively social events and the chance to experience the vibrant culture of Los Angeles! Accommodation and meals are on us, courtesy of the Kim Center APEC CoE. Plus, travel support is available for regulators from low-income economies.
For more information, contact:
Lawrence Liberti, Director – liberti@usc.edu