ISO 13485:2016 Active
v1.0
DocumentsSoftware LifecycleSW-003
Document Number
SW-003
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
IEC 62304 5.3
Tier Level
Tier 2 — SOP/Plan

System architecture with layered diagram, API design, data models, and component interactions.

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

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release