ISO 13485:2016 Active
v1.0
DocumentsRisk ManagementRM-003
Document Number
RM-003
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 acceptability determination using the defined risk acceptability matrix.

#risk-evaluation#acceptability#risk-matrix
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 14971:2019ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release