Document Number
DC-007
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
7.3.4
Tier Level
Tier 2 — SOP/Plan
Formal design review SOP including review stages, participant requirements, and documentation.
#design-review#meeting#minutes
Approval Status
DraftEffective: May 7, 2026
Regulatory Standards
ISO 13485:2016IEC 62304:2006+A1:2015
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Engineering Lead | Initial release |