DC-001
Design Control Procedure
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
Category
Design Controls
Master SOP for all design control activities per ISO 13485:2016 Clause 7.3.
#design-control#sop#iso-13485
Regulatory Standards
ISO 13485:201621 CFR Part 820
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Engineering Lead | Initial release |