ISO 13485:2016 Active
v1.0
DocumentsDesign ControlsDC-001
Document Number
DC-001
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
7.3
Tier Level
Tier 2 — SOP/Plan

Master SOP for all design control activities per ISO 13485:2016 Clause 7.3.

#design-control#sop#iso-13485
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 13485:201621 CFR Part 820

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release