DC-002
Design and Development Planning
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
7.3.1
Category
Design Controls
Design and development planning including project timelines, resource allocation, and team assignments.
#design-planning#project-plan
Regulatory Standards
ISO 13485:201621 CFR Part 820IEC 62304:2006+A1:2015
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Engineering Lead | Initial release |