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.
qointa Services brochures
Free
2 pages
Medical Device Software Development — service brochure
Medical device software development, from planning and requirements through risk management (ISO 14971), development and verification.
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Position papers
Free
5 pages
The Control Plane Is Part of the Trust
A companion reading from the device-management vendor seat — what the control plane must evidence, and when constraining a device is someone else’s regulatory problem
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Position papers
9 pages
Securing the Trial Device: Cybersecurity Obligations for Clinical DHTs
A networked device holding clinical data is a security artefact — and security is a data-integrity obligation, not optional hygiene.
Read the summary →A paper raised a question about your study?
The people who wrote these papers run the assessments. Bring the device and the protocol; fifteen minutes is enough to know whether it matters for your trial.
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