Global Regulatory Intelligence

Every regulation. Every jurisdiction. One knowledge engine.

Compliome is an AI research assistant that answers your questions across 21 CFR, FDA guidance, EU legislation, device clearances, drug approvals and pharmacology, and clinical trials, spanning the US, EU, UK, Canada, and Switzerland. Every answer comes with citations, evidence, and interactive visualizations from a knowledge engine of 1.2M+ data points.

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How does the EU MDR classification for this device compare to its FDA pathway?

Under the EU Medical Device Regulation, this device is Class IIb (Annex VIII, Rule 11), requiring Notified Body review. Its US equivalent is a 510(k) submission demonstrating substantial equivalence under 21 CFR 807.92, a materially different route with its own predicate logic.

EU MDR · Annex VIII 21 CFR 807.92 3 authorities compared

1.2M+

Knowledge points

Connected domains

US · EU · UK · CA · CH

Jurisdictions live today

Growing

New authorities added continuously

The four pillars

Not just the rules. Everything the rules touch, everywhere they apply.

Compliome connects regulatory text, medical science, competitive intelligence, and (soon) literature in one engine with the same cited, evidence-based answers across every domain.

Regulatory

Every authority, one engine

21 CFR, EU legislation, Swissmedic, and a growing list of global authorities, cited down to the section.

How does an EU MDR requirement compare to its US equivalent?

Med & Science

Drugs, targets & pathways

Pharmacology, mechanisms, disease and repurposing signal.

What's the MOA behind this drug class?

Intelligence

Orgs, trials & enforcement

Competitive and compliance signal across sponsors and authorities worldwide.

Which sponsors are active in this indication, in the US and the EU?

Soon Literature · soon

Published research

The next layer: peer-reviewed literature grounding, linked into the same engine.

What does the literature say about this pathway?

How it works

From question to cited answer in seconds.

Ask in plain English

Pose any question about regulatory pathways, predicate devices, drug precedent, pharmacology, or compliance requirements, in any jurisdiction we cover.

We query the engine

Compliome searches a knowledge engine of 1.2M+ regulatory and scientific data points using hybrid semantic retrieval.

Get a cited answer

Receive an evidence-based response with sources and interactive visualizations you can trust.

Why Compliome

See the connections others miss.

Most regulatory tools search one corpus at a time, or give you an answer you cannot verify. Compliome is built for the work that actually happens: comparing authorities, citing primary sources, and following how a rule connects to the science and sponsors behind it.

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FDAEUSwissmedic

Cross-border answers in one thread

Stop re-phrasing the same question for each authority. Compare how FDA, EU, and Swissmedic treat the same product class in a single cited answer.

click through to the source

Defensible in a meeting, not just plausible

Generic chatbots paraphrase. Every Compliome claim carries a numbered citation you can click through to the CFR section, guidance PDF, or trial record behind it.

matches meaning, not keywords

Finds the passage even when your wording differs

Regulations use precise legal language. Compliome matches what you mean, not just the words you typed, so the right section surfaces even if you never use the statute's exact phrasing.

85,000+ enforcement actions

See how a rule plays out in practice

Move past the text of the regulation. Compliome ties each section to the warning letters, recalls, and enforcement actions filed against it, so you see real-world consequences, not just requirements.

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Join regulatory, scientific, and intelligence professionals using Compliome to research faster and cite with confidence.

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