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
DeviceReg — regulatory classification and filing
Jurisdiction-specific classification, regulatory justification packages, change control and protocol-amendment impact mapping.
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Position papers
8 pages
Change Is the Risk: Managing App, OS and Firmware Updates Across a Live Trial
A feature added in a routine update can cross a perimeter mid-study. Why change is a regulated event — and how to tell which changes are material.
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Position papers
8 pages
Predetermined Change Control Plans (PCCP) for AI/ML in Trial DHTs
Why an evolving on-device model needs a pre-agreed change plan — and why the regulatory timeline is the part most easily misjudged.
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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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