ISO 13485:2016 Active
v1.0
DocumentsSecurity PrivacySEC-002
Document Number
SEC-002
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
4.1, HIPAA
Tier Level
Tier 2 — SOP/Plan

RBAC system, authentication requirements, and session management for all platform users.

#access-control#rbac#authentication#mfa
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
HIPAAGDPRISO 13485:201621 CFR Part 11

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release