ISO 13485:2016 Active
v1.0
DocumentsSoftware LifecycleSW-004
Document Number
SW-004
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
IEC 62304 5.4
Tier Level
Tier 2 — SOP/Plan

Module specifications, database schema, algorithm definitions, and interface specifications.

#detailed-design#sds#module-spec
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