ISO 13485:2016 Active
v1.0
DocumentsAI ML GovernanceAI-005
Document Number
AI-005
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Regulatory Affairs
Owner
Regulatory Affairs
ISO Clause
ISO 14971
Tier Level
Tier 2 — SOP/Plan

AI-specific risk assessment addressing model failures, bias, data quality, and algorithmic risks.

#ai-risk#bias#model-risk#algorithmic
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 14971:2019ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Regulatory AffairsInitial release