Document Number
PO-002
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Engineering Lead
Owner
Engineering Lead
ISO Clause
7.5.3
Tier Level
Tier 2 — SOP/Plan
Change management procedure for all changes to the SaMD after design freeze.
#change-control#sop#devops
Approval Status
DraftEffective: May 7, 2026
Regulatory Standards
ISO 13485:201621 CFR Part 820
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Engineering Lead | Initial release |