Leveraging Effective Post-Market Surveillance Strategies to Strengthen SaMD Compliance, Improve Signal Detection & Reduce Regulatory Risk
1:45 pm - Wednesday 9th December 2026
- Understanding common PMS and reporting challenges for SaMD by examining why organisations fail to recognise reportable events, struggle with adverse event identification and underutilise post-market data
- Exploring emerging challenges in AI-enabled products, including lessons learned from AI Airlock initiatives, dataset limitations and the implications of deploying AI systems in real-world healthcare environments
- Integrating cybersecurity into PMS frameworks by treating cyber incidents and security breaches as part of ongoing post-market surveillance activities to improve risk management and regulatory compliance
