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
DeviceOps — logistics and lifecycle
Labelling, UDI, importer-of-record, chain of custody, mid-study replacement and field safety corrective actions.
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Position papers
Free
6 pages
What the Trial Needs From the Handset Maker
A companion reading from the phone manufacturer / OEM (original equipment manufacturer) seat — what the trial needs from you, and why none of it is your obligation
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Position papers
Free
6 pages
Your Device, and the System It Joins
A companion reading from the wearable / biosensor manufacturer seat — your own obligations, and the system the bridge creates
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Position papers
Free
6 pages
The Provisioning Chain’s Inherited Duties
A companion reading from the logistics / provisioning vendor seat — how sourcing and configuration draw operator and end-of-life duties
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Position papers
Free
5 pages
Where the Data Actually Travels
A companion reading from the connectivity provider seat — what routing and egress do, and do not, do to a trial’s data-protection position
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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
10 pages
Labelling, UDI and Supply-Chain Transparency for Trial DHTs
Why the labelled article is the software, the supplied unit or the sensor — never the phone, tablet or gateway that carries it — and why BYOD makes identification harder, not exempt
Read the summary →A paper raised a question about your study?
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