Document Number
AI-004
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Clinical Affairs
Owner
Clinical Affairs
ISO Clause
ISO 14971
Tier Level
Tier 2 — SOP/Plan
Clinical validation study protocol for DXA correlation and clinical performance evaluation.
#clinical-validation#dxa#clinical-study#performance
Approval Status
DraftEffective: May 7, 2026
Regulatory Standards
ISO 14971:2019ISO 13485:201621 CFR Part 820EU MDR 2017/745
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Clinical Affairs | Initial release |