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DHF-GKW3-001 - Geko W3 Design History File Index

Geko W3 Device File v1.0 Pending

Owner: Geko W3 Program Lead | Effective: 2026-03-17 | Next Review: 2026-09-17

DHF-GKW3-001 Geko W3 Design History File Index

Device Identification

Device: Geko W3
Intended Use: Neuromuscular electro-stimulation therapy support

DHF Contents

Design and development plan
User needs and design inputs
Design outputs and architecture
Design reviews
Verification records
Validation records
Risk management file link
Release and transfer evidence

Control Notes

All referenced records must be approved and current.