Postmarket AI Performance Monitoring (AI-07)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
What it is
the postmarket AI performance monitoring plan. Defines how real-world performance is monitored after release — drift detection, logging strategy and re-training triggers — structured to feed back into the PCCP and the risk file.
What it covers
- Real-world performance monitoring strategy
- Drift detection methods and thresholds
- Logging and data-capture requirements
- Re-training and update triggers
- Feedback loop into the PCCP and risk file
Format
One fully editable Microsoft Word document. Built from public primary sources (IMDRF GMLP monitoring principles, FDA guidance). Multi-jurisdictional requirements integrated as inline notes. Instant download after purchase.
Part of the kit
This document is one of 10 in the AI/ML Medical Device Documentation Kit. Buying the complete kit (€499) instead of the 10 documents individually (€690) saves ~28% and adds the README and Excel Master Index.
€69.00
