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
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
9 pages
Who Is the Manufacturer? Economic-Operator Roles in DHT Supply Chains
How provisioning, importing, kitting and modifying a device assign manufacturer, importer and distributor duties — often by operation of law.
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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
11 pages
Global Reconciliation: FDA, EU, PMDA, NMPA and UK Requirements for DHTs
Why the shared requirements carry across markets and the local differences do not — and how to decide when a per-jurisdiction assessment is actually needed.
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Position papers
8 pages
ALCOA+ on the Device: Device-Side Data Integrity in GCP
When a device captures trial data — a handset, a wearable, a home instrument or the gateway that relays them — attribution, time and protection against alteration are decided on the device, and no validated database can decide them later.
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