ISO 13485:2016 Active
v1.0
DocumentsSoftware LifecycleSW-001
Document Number
SW-001
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
IEC 62304 5.1
Tier Level
Tier 2 — SOP/Plan

Software development planning including IEC 62304 Class B requirements and development standards.

#development-plan#iec-62304#planning
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