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.
Position papers
Free
16 pages
Regulatory Impact Assessment (RIA) for Devices and Systems in Clinical Trials
Why a device’s role and triggers — not the hardware — determine whether an RIA is required
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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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Position papers
12 pages
Vigilance and Post-Market Surveillance for Trial DHTs
Why the reporting route turns on what the device is — and why meeting one route never discharges another.
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Position papers
8 pages
Designed for the Hand That Holds It: Human Factors and Use-Safety in Trial DHTs
Why usability and use-error are regulated concerns for participant-facing devices — and why the population, and the risk, set the bar.
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Position papers
8 pages
Risk-Based Monitoring and Device Telemetry in Decentralised Trials
Why the device is a monitorable data source — and why its telemetry belongs in the risk-based monitoring plan, not outside it
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