ISO 13485:2016 Active
Guest
·
Role
v1.0
SW-001
Software Development Plan
Draft
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

VersionDateAuthorDescription
v1.0May 7, 2026Engineering LeadInitial release