SW-001
Software Development Plan
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
IEC 62304 5.1
Category
Software Lifecycle
Software development planning including IEC 62304 Class B requirements and development standards.
#development-plan#iec-62304#planning
Regulatory Standards
IEC 62304:2006+A1:2015ISO 13485:2016
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Engineering Lead | Initial release |