Resource library
Our regulatory position papers and whitepapers on digital health technologies in clinical trials. Three download without an account; a free account opens the rest after email confirmation and personal approval, usually within one business day. No sales calls attached.
Device360 Brochures
Free
4 pages
Device360 — the full suite
How the eight modules fit together into one governance loop, from classification to inspection readiness.
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Device360 Brochures
Free
2 pages
DeviceReg — regulatory classification and filing
Jurisdiction-specific classification, regulatory justification packages, change control and protocol-amendment impact mapping.
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Device360 Brochures
Free
2 pages
DeviceFit — fit-for-purpose validation
Technical, clinical and operational validation aligned to ISO 14971, IEC 62366-1, FDA QSR, EU MDR Annex I and ICH-GCP.
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Device360 Brochures
Free
2 pages
DeviceOps — logistics and lifecycle
Labelling, UDI, importer-of-record, chain of custody, mid-study replacement and field safety corrective actions.
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Device360 Brochures
Free
2 pages
DeviceConnect — data interoperability
Data-flow mapping, ALCOA+ metadata standardisation, time-synchronisation controls and AI/ML traceability.
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Device360 Brochures
Free
2 pages
TrainReady — training and certification
Role-specific multilingual training for patients, sites and vendors, with TMF-ready logs and retraining triggers.
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Device360 Brochures
Free
2 pages
AuditPrep — inspection readiness
Audit-ready documentation binders, mock audits, CAPA logs and portfolio lifecycle traceability.
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