AI-SC 9 - Post-market surveillance and quality assurance of AI tools
March 5, 12:15 - 13:15 CET
2 min
Chairpersons' introduction
12 min
Intention and concept of post-market surveillance
To learn what the medical device regulations in the EU mandate in regard to manufacturer responsibilities for PMS.
To appreciate the burden placed on hospitals to assist manufacturers in conducting PMS effectively.
To understand practical systems for managing AI post market surveillance.
12 min
Why PMS? Comparison of 3 AI lung nod detection systems
To learn how AI-based tools support lung nodule reporting, with particular strengths in detection and longitudinal follow-up.
To appreciate the limitations of histopathological assessment for pulmonary nodules and how AI can complement, but not replace, current diagnostic pathways.
To understand the clinical implications and future potential of AI-supported lung reporting, including workflow integration, patient management, and potential outcome improvement.
12 min
Solution overview on monitoring
To learn the fundamentals and techniques of continuous AI monitoring.
To appreciate the variability and utility of objective and subjective metrics.
To understand the practical approach to clinical AI monitoring.
22 min
Discussion with the audience: Post-market surveillance: How much do we need?