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 step-by-step PMS workflow for QA/RA teams
• Real-world case study on AI performance drift

We conclude with a practical checklist to help QA/RA teams ensure compliance while keeping patients safe.

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

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