Search

Home > Medical Device made Easy Podcast > Post-Market Surveillance for Software and AI Devices
Podcast: Medical Device made Easy Podcast
Episode:

Post-Market Surveillance for Software and AI Devices
Category: Business
Duration: 00:00:00
Publish Date: 2025-09-24 22:52:35
Description:
Miniature Post-Market Surveillance for Software and AI Devices monir el azzouzi easy medical device

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

</td> </tr> <tr> <td> Total Play: </td> <td></td> <td> 0 </td> </tr> </table> </form> <audio controls autoplay style= Your browser does not support the audio element.