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Post-Market Surveillance for Software and AI Devices
Post-Market Surveillance for Software & AI Devices – A QA/RA Guide
Software evolves with updates. AI models may even change with real-world data. That makes Post-Market Surveillance (PMS) for digital medical devices very different from traditional hardware.
In this article, based on the podcast episode, we cover:
How PMS differs for software, cloud, and AI-based devices
Usage monitoring & anomaly detection through dashboards and KPIs
Revalidation of updates and retrained AI algorithms
Regulatory frameworks: EU MDR/IVDR, FDA’s PCCP, IMDRF guidelines
Supplier and infrastructure considerations
A…
The skinny
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