ISO 13485:2016 Active
Guest
·
Role
v1.0
AI-003
AI Performance Monitoring
Draft
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
QA Engineer
Owner
QA Engineer
ISO Clause
ISO 14971
Category
AI ML Governance

Post-market AI monitoring including performance drift detection and alert thresholds.

#monitoring#performance#drift-detection#pmcf
Regulatory Standards
ISO 14971:2019ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026QA EngineerInitial release