Suricat - Compliance Intelligence Platform
regulatory compliance professionals analyzing medical device documentation quality management system audit preparation
Compliance Intelligence Platform

Compliance Intelligence for Regulated Life Sciences

Continuous compliance visibility across your quality system documentation. Explainable, audit-defensible insights with human oversight by design.

FDA 21 CFR Part 11
ISO 13485:2016
EU MDR/IVDR
quality assurance team reviewing compliance documents regulatory affairs medical device traceability audit preparation

Our Mission

We help medical device companies manage compliance more easily and confidently by giving teams clear insights, highlighting issues before they become problems, and supporting faster delivery of life-saving technologies.

corporate team collaborating on business strategy in modern office

Document Chaos & Audit Stress

Fragmented documents across systems

DHF, DMR, CAPA, and risk files scattered across multiple platforms with no unified view.

Conflicting information

Inconsistencies between requirements, design outputs, and verification records.

Manual audit preparation

Weeks spent gathering evidence and explaining document gaps to auditors.

Poor traceability

Broken links between requirements, risks, tests, and validation protocols.

stressed business professional with scattered documents and paperwork on desk
quality assurance team analyzing compliance data on digital platform workspace

What Suricat Does

Reads and analyzes documents

Automatically ingests DHF files, SOPs, risk analyses, and validation protocols.

Identifies gaps and risks

Surfaces inconsistencies and compliance vulnerabilities before they become audit findings.

Maps to regulatory requirements

Links your quality system directly to FDA, ISO, and EU MDR requirements.

Provides evidence-backed insights

Humans review and approve everything. Suricat provides intelligence, not decisions.

Explainable AI & Human Oversight

Transparency over automation. Evidence and source references for every insight. Aligned with FDA expectations for AI in medical devices.

compliance professional reviewing AI generated insights on digital dashboard

Explainable reasoning

Every insight includes source documents, regulatory clauses, and clear reasoning chains.

Evidence and source references

Direct links to specific document sections, requirement clauses, and regulatory standards.

Human-in-the-loop

Your experts maintain full control over all compliance decisions and document changes.

How Suricat Works

enterprise compliance workflow diagram showing document flow through AI analysis system with professional clean design modern office setting

Rules Engine

Captures regulatory requirements from FDA, ISO 13485, and EU MDR. Checks documents against established compliance rules with precision.

Advisory Layer

Interprets context and meaning while leaving decisions to humans who understand your products best.

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Secure Enterprise Environment

Built for medical device companies with enterprise-grade security.

QMS Integration

Integrates with existing quality management systems seamlessly.

Flexible Deployment

Cloud, private cloud, or on-premises deployment options.

Key Use Cases

Comprehensive compliance intelligence for every stage of the product lifecycle.

Audit Readiness

Generate comprehensive audit packages in minutes, not weeks.

DHF / DMR Traceability

Complete traceability matrices linking requirements to tests and validations.

CAPA & Risk Alignment

Ensure corrective actions address identified risks and root causes.

PMS & Post-Market

Monitor post-market surveillance data against design requirements.

Version Comparison

Track changes across document revisions and compliance impact.

Regulatory Clause Mapping

Direct links between your documents and specific regulatory requirements.

Built for Regulated Enterprises

Security & Data Privacy

SOC 2 Type II, HIPAA compliance, and encrypted data processing.

Validation Readiness

IQ/OQ/PQ documentation and CSV-ready deployment packages.

Deployment Options

Cloud, private cloud, or on-premises to meet your security requirements.

QMS Integration

Seamless integration with Veeva Vault, MasterControl, and other QMS platforms.

secure enterprise data center infrastructure compliance platform

Who Uses Suricat

Built for compliance professionals across the medical device lifecycle.

regulatory affairs professional

Regulatory Affairs

Submission preparation and regulatory intelligence.

quality assurance professional

Quality Assurance

QMS oversight and audit management.

design development engineer

Design & Development

Design control and traceability management.

internal audit compliance professional

Internal Audit

Risk assessment and compliance verification.

Why It Matters

Transparency
Human Oversight
Evidence-Based Decisions

Suricat helps teams catch issues early, prepare for audits faster, improve consistency, and strengthen compliance workflows — while keeping humans in charge.

75%

Faster Audit Prep

90%

Reduced Manual Review

100%

Traceability Coverage

Zero

Audit Surprises

Founding Team

Built by regulatory and quality experts with decades of real-world experience.

Mujeeb CEO professional headshot

Mujeeb

CEO, Strategy & Product

Product vision and regulatory strategy.

Fahad CTO professional headshot

Fahad

CTO, System Architecture

Enterprise AI and security infrastructure.

Kim regulatory professional headshot

Kim

Regulatory Strategy

20+ years FDA and EU MDR experience.

Matt quality advisor professional headshot

Matt

Quality & Regulatory Advisor

Quality systems and audit preparation.

Latest Insights

Expert perspectives on regulatory compliance, quality management, and audit readiness.

FDA compliance regulatory documentation medical device
Regulatory•5 min read

FDA's New AI Guidance: What MedTech Companies Need to Know

Understanding the latest FDA expectations for AI transparency and validation in medical device quality systems.

Read More
quality management system audit preparation compliance
Quality Systems•7 min read

Audit Preparation: From Weeks to Days with Intelligence

How compliance intelligence platforms are transforming audit readiness for medical device companies.

Read More
design control traceability matrix DHF DMR
Best Practices•6 min read

Complete Traceability: Linking DHF, DMR, and Risk Analysis

Building audit-defensible traceability matrices that connect requirements to verification and validation.

Read More
View All Articles
compliance professional answering questions regulatory affairs support

Frequently Asked Questions

Everything you need to know about Suricat

Does Suricat replace our QMS?

No. Suricat integrates with your existing QMS to provide intelligence and insights. It reads your documents, identifies gaps, and surfaces compliance risks — but your team maintains full control over all records and decisions.

How does Suricat ensure AI transparency?

Every insight includes source references, regulatory clause mappings, and clear reasoning chains. Suricat provides explainable AI that meets FDA expectations for transparency and validation in medical device applications.

What deployment options are available?

Suricat offers cloud, private cloud, and on-premises deployment options to meet your security and compliance requirements. All deployments include enterprise-grade security, SOC 2 Type II compliance, and validation support.

How long does implementation take?

Typical implementation ranges from 4-8 weeks, including data integration, user training, and validation. We provide IQ/OQ/PQ documentation and work closely with your team to ensure smooth deployment and adoption.

Which regulations does Suricat support?

Suricat supports FDA 21 CFR Part 11, ISO 13485:2016, EU MDR/IVDR, and other global medical device regulations. Our rules engine is continuously updated to reflect the latest regulatory requirements and guidance documents.

Bring Clarity to Compliance

See how Suricat helps your team stay audit-ready without losing control.