AEGIS: An Operational Infrastructure for Post-Market Governance of Adaptive Medical AI Under US and EU Regulations

1. 1Implementing Predetermined Change Control Plan (PCCP) for iterative model updates
2. 2Conducting Post-Market Surveillance (PMS) to monitor AI system performance
3. 3Developing governance frameworks that balance safety and continuous improvement
4. 4Integrating AEGIS with existing regulatory mechanisms to ensure compliance

Regulatory compliance teams and AI engineers in medical device companies benefit from AEGIS as it enables them to ensure safety and continuous improvement of adaptive medical AI systems

💡 AEGIS provides a framework for ensuring safety and continuous improvement of adaptive medical AI systems under US and EU regulations

💡 AEGIS: Operational infrastructure for post-market governance of adaptive medical AI #AIinMedicine #RegulatoryCompliance