Medical Device Document Library

Structured for ISO 13485 controlled records, version history, and audit-ready traceability.

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Geko T3

Geko W3

Smart Bracelet

Smart Ring

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Use the same Document Code for revisions. Example: upload SOP-DC-001 with Version 2.0 to publish Version 2 and automatically supersede older current versions.

Doc ID	Title	Category	Version	Status	Owner	Next Review	Action
CHK-ISO-001	Audit Readiness Checklist	Audit	1.0	Pending	Quality Manager	2026-09-17	Open
SOP-CAPA-001	CAPA Procedure	Quality Improvement	1.0	Pending	Quality Manager	2027-03-17	Open
SOP-DD-001	Design and Development Control Procedure	Design Control	1.0	Pending	Regulatory Lead	2027-03-17	Open
TM-001	Design Traceability Matrix	Design Control	1.0	Pending	Systems Engineer	2027-03-17	Open
SOP-DC-001	Document Control Procedure	QMS	1.0	Pending	Document Controller	2027-03-17	Open
SOP-IA-001	Internal Audit Procedure	Audit	1.0	Pending	Lead Auditor	2027-03-17	Open
SOP-MR-001	Management Review Procedure	Management	1.0	Pending	Executive Sponsor	2027-03-17	Open
QM-001	Quality Manual	QMS	1.0	Pending	Quality Manager	2027-03-17	Open
SOP-RM-001	Risk Management Procedure	Risk	1.0	Pending	Safety Officer	2027-03-17	Open
SOP-SW-001	Software Lifecycle Procedure (IEC 62304 aligned)	Software	1.0	Pending	Software QA	2027-03-17	Open
DIR-001	Tenant Directory Context Record	Governance	1.0	Pending	IT Governance	2027-03-17	Open

Doc ID	Title	Category	Version	Status	Owner	Next Review	Action
DHF-GKT3-001	Geko T3 Design History File Index	Device File	1.0	Pending	Geko T3 Program Lead	2026-09-17	Open
DMR-GKT3-001	Geko T3 Device Master Record	Device File	1.0	Pending	Manufacturing Engineer	2026-09-17	Open
RMF-GKT3-001	Geko T3 Risk Management File	Risk	1.0	Pending	Safety Officer	2026-09-17	Open

Doc ID	Title	Category	Version	Status	Owner	Next Review	Action
DHF-GKW3-001	Geko W3 Design History File Index	Device File	1.0	Pending	Geko W3 Program Lead	2026-09-17	Open
DMR-GKW3-001	Geko W3 Device Master Record	Device File	1.0	Pending	Manufacturing Engineer	2026-09-17	Open
RMF-GKW3-001	Geko W3 Risk Management File	Risk	1.0	Pending	Safety Officer	2026-09-17	Open

Doc ID	Title	Category	Version	Status	Owner	Next Review	Action
DHF-DEV1-001	Smart Bracelet Design History File Index	Device File	1.0	Pending	Smart Bracelet Program Lead	2026-09-17	Open
DMR-DEV1-001	Smart Bracelet Device Master Record	Device File	1.0	Pending	Manufacturing Engineer	2026-09-17	Open
RMF-DEV1-001	Smart Bracelet Risk Management File	Risk	1.0	Pending	Safety Officer	2026-09-17	Open