ISO 13485:2016 Active
Guest
·
Role
v1.0
SEC-002
Access Control
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
4.1, HIPAA
Category
Security Privacy

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

#access-control#rbac#authentication#mfa
Regulatory Standards
HIPAAGDPRISO 13485:201621 CFR Part 11

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release