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A specialist replies within one business day — not an account manager, and not a form letter. If your question has a short answer you get the short answer.

What to bring

The two things that make a first conversation useful are one device and one protocol: what the technology is, and what the protocol asks it to do. That is enough for us to tell you which regulatory perimeters it opens. Vendor datasheets and draft protocol sections help; you do not need an NDA in place for a scoping call.

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Read the thinking behind this

Our regulatory position papers and whitepapers. Three download without an account; a free account opens the rest.

The qointa brochure BrochuresFree

The qointa brochure

The qointa brochure in print format: what we do, for whom, and how an engagement runs.

Download PDF →
Regulatory Impact Assessment (RIA) for Devices and Systems in Clinical Trials Position papersFree

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

Read the summary →
Digital Trials and the Device Perimeter: A Regulatory Primer Position papersFree

Digital Trials and the Device Perimeter: A Regulatory Primer

A plain-language entry point to the regulatory questions raised by the devices and systems a clinical trial relies on — wearables and sensors, home and point-of-care instruments, apps and eCOA platforms, clinical systems, and the phones and tablets that connect them

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All papers in the library →