ISO 13485:2016 Active
v1.0
DocumentsSoftware LifecycleSW-007
Document Number
SW-007
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
QA Engineer
Owner
QA Engineer
ISO Clause
IEC 62304 5.7
Tier Level
Tier 2 — SOP/Plan

System test specifications verifying the complete software system meets its requirements.

#system-testing#verification#qa
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
IEC 62304:2006+A1:2015ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026QA EngineerInitial release