ISO 13485:2016 Active
v1.0
DocumentsRisk ManagementRM-001
Document Number
RM-001
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
ISO 14971:2019
Tier Level
Tier 2 — SOP/Plan

Risk management approach establishing the framework for all SaMD risk activities.

#risk-management#planning#iso-14971
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 14971:2019ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release