ISO 13485:2016 Active
v1.0
DocumentsSoftware LifecycleSW-005
Document Number
SW-005
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
QA Engineer
Owner
QA Engineer
ISO Clause
IEC 62304 5.5
Tier Level
Tier 2 — SOP/Plan

Unit test specifications and acceptance criteria for all software units per IEC 62304 Class B.

#unit-testing#verification#testing
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