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Full Multi-Perimeter Assessment

Multiple devices or multiple jurisdictions, where the answers differ by market and the interactions matter.

Fee quoted on scope
scoped per engagement
4–8 weeks
typical turnaround
7
perimeters assessed

When a Snapshot is not enough

A device or system can be out of scope in one market and squarely in scope in three others. A portfolio can be individually defensible and collectively unmanageable. And the moment two devices feed the same endpoint, the questions interact.

This is the same method at portfolio scale: every device, every market, every perimeter, with the divergences made explicit rather than discovered during a submission.

EUUSUKCHJPCGM—Watch——SpirometereCOA app———BYOD phone—answers divergethe same device, five markets, five answers — and the interactions matter

Who this is for

Sponsors, CROs and technology vendors running one protocol across several markets, or one market with several devices feeding the same data. It suits you if the device inventory itself is uncertain — if nobody can currently produce a single list of every technology in the study, who supplies each one, and which endpoint depends on it. Building that list is part of the work, not a precondition for starting it.

What you receive

  • Full assessment across every device and jurisdiction in scope
  • Comparative jurisdiction matrix showing where answers diverge
  • Complete decision register with per-device entries
  • Consolidated trigger register across the portfolio
  • Evidence index and gap list with remediation priorities

What you provide

  • Device inventory, however incomplete — building it is part of the work
  • Protocol and any amendments
  • Target markets and submission plans
  • Supplier and economic-operator arrangements per market
  • Existing quality documentation and prior assessments

More details

What you provide
Whatever inventory exists, however incomplete, plus the protocol and any amendments already executed. Beyond that: your target markets and the submission sequence you intend to follow, the supplier and economic-operator arrangement in each market — who manufactures, who relabels, who imports, under whose name — and any quality documentation or prior assessments already held. Where the inventory has holes, we tell you which questions to put to which supplier.
What is excluded
A Full Multi-Perimeter Assessment covers the devices and jurisdictions frozen into scope at the written quote. It does not include: devices added to the protocol after scope freeze — those are assessed by agreement or by Snapshot RIA; execution of any remediation identified; preparation or submission of a regulatory filing in any market; validation testing or evidence generation; notified body engagement on your behalf; and it is not legal advice. It records a regulatory position per device per market and the reasoning behind it — it does not bind a regulator, notified body or inspector to the same conclusion.
What happens next
The comparative matrix shows you where the answers diverge, and divergence is what sets sequence: the market with the tightest classification usually determines the evidence everything else inherits. The consolidated trigger register tells you which changes would move which device in which market. From there you choose whether to close the gaps yourself, with us, or not at all — only the modules that apply are recommended. Portfolios of this size normally move into scheduled re-assessment, because a portfolio assessed once and left alone is out of date on the first firmware release.
What the output looks like

You receive a single controlled package:

1. Assessment report: the decision for each of the seven perimeters, for each device, in each jurisdiction in scope, with the reasoning and the regulatory basis cited to article or clause level.

2. Comparative jurisdiction matrix: one view showing where the answers diverge by market, and why, so the divergence is a decision you made rather than a surprise during submission.

3. Decision register: a per-device entry recording what was decided, on what basis, by whom, on what date, and what would change it. Versioned, so the history survives.

4. Consolidated trigger register: every re-assessment trigger across the portfolio in one place: firmware releases, OS updates, protocol amendments, supplier changes, algorithm retraining.

5. Evidence index and gap list: every document relied on, indexed so an inspector can follow the reasoning without asking you to reconstruct it, with the gaps prioritised by what they block.

Where this sits among the eight

Every assessment leaves the same controlled artefacts — a recorded decision, the reasoning behind it, and the evidence index that makes it defensible. They differ in scope. This one is the whole estate in one pass.

See all eight side by side →

Request this assessment

Tell us about the device and the protocol. We come back with a written scope, price and date — no obligation.

Name, manufacturer and model if you have it. List every item if there is more than one.
The single most important field. Screening, primary endpoint, secondary endpoint, safety monitoring, engagement only?
Which specific endpoints, and whether any safety decision is informed by its output.
e.g. EU, US, UK, Japan, Canada, China.
Who supplies it, whether you relabel, reconfigure or assemble kits, and whether you import into the EU.
Firmware or app updates expected, protocol amendments planned, algorithm retraining, supplier changes.
Vendor declarations, CE certificates, validation reports, prior assessments, DPIAs.
A date or a milestone.

We treat everything you send as confidential and handle it in line with our Privacy Policy. Do not include patient-identifiable data — we never need it.

Before you buy: the service overview

Free, no account needed. Every service line and the framework each is written against.

Two papers behind this assessment

Free to read with a qointa account. No sales call attached.

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

Download PDF →
You Can Delegate the Work, Not the Accountability: Vendor Qualification and Oversight under ICH E6(R3) Position papers

You Can Delegate the Work, Not the Accountability: Vendor Qualification and Oversight under ICH E6(R3)

The sponsor’s duty to qualify and oversee its DHT vendors — distinct from who holds the economic-operator role.

Read the summary →

All papers in the library →