ISO 13485:2016 Active
v1.0
DocumentsRisk ManagementRM-006
Document Number
RM-006
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

Overall residual risk evaluation and benefit-risk analysis for regulatory submission.

#risk-report#residual-risk#benefit-risk
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 14971:2019ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release