ISO 13485:2016 Active
v1.0
DocumentsAI ML GovernanceAI-003
Document Number
AI-003
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
QA Engineer
Owner
QA Engineer
ISO Clause
ISO 14971
Tier Level
Tier 2 — SOP/Plan

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

#monitoring#performance#drift-detection#pmcf
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 14971:2019ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026QA EngineerInitial release