ISO 13485:2016 Active
v1.0
DocumentsDesign ControlsDC-004
Document Number
DC-004
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
7.3.3
Tier Level
Tier 2 — SOP/Plan

Architecture and design outputs including layered architecture, API design, and database schema.

#architecture#design-output#api
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
ISO 13485:2016IEC 62304:2006+A1:2015

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release