ISO 13485:2016 Active
Guest
·
Role
v1.0
AI-001
AI Model Governance Plan
Draft
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
ISO 14971
Category
AI ML Governance

AI lifecycle management covering model development, validation, deployment, and monitoring.

#ai-governance#ml-lifecycle#model-management
Regulatory Standards
ISO 14971:2019ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release