The Compliance Intelligence Platform Built for Highly Regulated Industries Learn more

The Sentinel of
Compliance Intelligence.

Suricat is the inspection-ready compliance intelligence platform that detects misalignment and delivers defensible findings before regulators do.

Introducing
Compliance intelligence for medical device

The QMSR enforcement deadline has passed.
Are you inspection-ready today?

The cost of compliance and audit failure isn't just financial.

Suricat transforms regulatory compliance from episodic validation into continuous alignment, operating above existing systems to detect misalignment early and maintain inspection readiness.

The Price of Getting It Wrong

$14.82M vs $5.47M

non-compliance costs 2.7× more than staying compliant.

Ponemon Institute / Globalscape

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Revenue at Risk

2–4%

of annual revenue lost to compliance failures and remediation.

International Quality Federation / ASQ

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Enforcement Is Intensifying

417% surge

in fines (H1 2025) $1.23B in penalties in just six months.

Fenergo / FinTech Global

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Complexity Is Increasing

85%

of executives report compliance requirements are becoming more complex.

PwC Global Compliance Survey 2025

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Regulation Is a Constraint

64%

of CEOs identify regulation as the top barrier to performance.

PwC Global Compliance Survey 2025

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The Market Is Responding

$63B → $135B

by 2030 investment reflects the scale of the problem.

MarketsandMarkets / Grand View

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Why Suricat

Built for continuous compliance intelligence.

Compliance does not fail all at once. It drifts quietly across documents, systems, and teams until an inspector finds what no system ever flagged. Suricat is that missing layer that makes alignment continuous.

Suricat's Mission

To transform regulatory compliance through explainable intelligence that detects misalignment early, preserves human accountability, and enables inspection-ready decisions.

Built by Practitioners

Suricat was built by practitioners with decades of experience in regulated environments, where documentation alignment determines whether organizations pass inspections, maintain approvals, and sustain operational continuity.

The Structural Problem

Compliance remains episodic in a world that demands continuous alignment. Organizations still rely on periodic reviews, manual reconciliation, and audit preparation cycles to validate compliance. Systems store records. Teams manage workflows. But no system continuously evaluates whether documentation remains aligned as requirements, processes, and evidence evolve.

Why Existing Systems Fall Short

Systems of record store documentation, enforce workflows, and preserve validation boundaries. They are essential and they will remain so.

What they were never designed to do is reason across documentation or evaluate whether alignment is sustained as systems and requirements evolve. They preserve information.

The Compliance Intelligence Platform

Suricat operates above existing systems of record to continuously maintain regulatory alignment across documentation ecosystems. It does not replace validated environments or disrupt existing infrastructure. It adds the capability those systems were never designed to provide.

How It Works

Suricat connects read-only to enterprise systems and structures documentation into a canonical intelligence model reflecting how regulatory requirements are interpreted in practice. It evaluates evidence credibility, reasons across documents and regulatory expectations, and identifies divergence as it emerges.

What Suricat Enables

Misalignment is identified early before it becomes an audit finding. Regulatory expectations are continuously evaluated against current documentation. Every conclusion traces back to source documents and governing requirements, creating the clarity and defensibility that inspection readiness demands.

Designed for Regulated Environments

Suricat preserves existing systems, validation boundaries, and human accountability. Its reasoning is explainable. Its outputs are inspection-defensible. Rather than replacing professional judgment, it strengthens it by providing structured, traceable intelligence that supports every regulatory decision.

Platform

How Suricat Works

Suricat introduces the Compliance Intelligence Platform, a new category built for regulated environments. It continuously evaluates alignment across documentation as it evolves, transforming compliance from periodic verification into a state that is always current, explainable, and inspection-ready.

The Intelligence Layer

Suricat operates as a neutral, read-only intelligence layer above existing systems of record. It does not replace validated infrastructure or alter system boundaries.

abstract visualization of a neutral intelligence layer hovering above enterprise systems, glowing digital mesh, dark background

No Rip and Replace

Your QMS, RIM platforms, document control systems, and validation infrastructure remain exactly as they are.

enterprise IT systems interconnected with a non-invasive glowing overlay, symbolizing seamless integration, dark background

Human Accountability

Suricat surfaces intelligence. Qualified professionals make every decision.

stylized human silhouette interacting with a glowing digital decision matrix, symbolizing human oversight, dark background

Canonical Intelligence Schema

Every document entering Suricat is transformed into structured, traceable evidence that reflects how experienced regulatory professionals evaluate artifacts during inspections.

documents dissolving into a structured, glowing canonical data schema, abstract digital art, dark background

Quality Validation Rating

Suricat continuously evaluates documentation through a confidence scoring system that determines inspection readiness.

high-tech circular gauge or dashboard interface showing a high validation score, glowing elements, dark background

Bounded Reasoning

Suricat's bounded reasoning engine is a proprietary architecture purpose-built for regulated environments where an incorrect output is not an inconvenience.

abstract AI core contained within strict geometric boundaries, symbolizing bounded reasoning, glowing purple and blue, dark background

The Regulatory Ontology

At the core of Suricat is a proprietary knowledge framework encoding how regulations are interpreted in practice.

complex 3d network graph representing a regulatory ontology, interconnected glowing nodes, dark background

Read-Only by Design

Suricat integrates across enterprise systems without modifying a single record.

digital scanner passing over documents emitting a safe blue light, symbolizing read-only access, dark background

From Episodic to Continuous

Compliance has traditionally been managed as a periodic activity, where alignment is reconstructed before audits and inspections.

glowing infinity loop formed by data streams, symbolizing continuous compliance monitoring, dark background

Deployment

Suricat is delivered as a secure SaaS platform, enabling rapid adoption without disrupting validated environments.

secure cloud infrastructure diagram with rapid deployment arrows, glowing digital elements, dark background
Built for highly regulated industries

Compliance intelligence wherever documentation alignment is mission-critical

Built for the compliance complexity of highly regulated industries — not adapted from generic tools.

Available Now

Medical Devices

FDA design controls, 21 CFR Part 820, ISO 13485, and the full DHF-to-submission compliance stack

View industry page
Coming Soon

Biotechnology

Advanced therapy and biologics regulatory intelligence

Coming Soon

Pharmaceuticals and Biopharma

Comprehensive drug development and manufacturing compliance

Coming Soon

Clinical Trials

Trial master file and protocol alignment compliance

Ready to Get Started?