Suricat - Compliance Intelligence Platform
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Next-Gen Quality Management

Compliance
Intelligence for
MedTech.

Clear insights across your quality and regulatory documents without taking control away from your experts.

ISO 13485:2016
EU MDR 2017/745
IEC 62304
ISO 14971
FDA 21 CFR PART 11
ISO 13485:2016
EU MDR 2017/745

Our Mission

We help medical device, pharmaceutical, and biotech companies maintain continuous compliance by providing intelligent monitoring across quality system documentation—enabling teams to identify risks early, maintain audit readiness, and accelerate product delivery while meeting FDA, ISO, and EU regulatory requirements.

Intelligent Gap Analysis

Automatically detect inconsistencies between your design history files and regulatory requirements.

Automated Traceability

Link requirements to risks and tests effortlessly, creating an unbreakable chain of evidence.

Audit-Ready Reporting

Generate compliant documentation packages in seconds, significantly reducing audit preparation time.

The Problem We Solve

Conflicting or inconsistent documentation

Critical discrepancies between design files, risk assessments, and validation reports.

Stressful, last-minute audit preparation

Weeks spent scrambling to gather evidence and explain document gaps.

Slow reviews and poor traceability

Manual cross-referencing delays approvals and increases compliance risk.

High risk of mistakes or auditor findings

Human oversight in complex documentation can lead to costly non-conformances.

Heavy burden on Regulatory and Quality teams

Experts spend time hunting for information instead of making strategic decisions.

Compliance Status
42 Issues Found
Critical
High Priority
Medium
Last scan: 2 hours ago
Documents Everywhere•No Clear Connections•High Risk•High Effort•
Documents Everywhere•No Clear Connections•High Risk•High Effort•

What Suricat Does

Intelligent compliance analysis that works alongside your team

Reads and analyzes existing documents

Automatically ingests DHF files, SOPs, risk analyses, and validation protocols to build a comprehensive understanding of your quality system.

Highlights mismatches and gaps

Identifies inconsistencies between requirements, design outputs, verification records, and regulatory standards in real-time.

Flags potential risks

Surfaces compliance vulnerabilities before they become audit findings, giving your team time to address issues proactively.

Shows what needs attention

Prioritizes compliance issues based on risk, regulatory importance, and impact on product safety and effectiveness.

Reduces audit preparation time

Generate audit-ready documentation packages in seconds, cutting preparation time from weeks to minutes.

Improves decision-making

Provides clear, data-driven insights that help teams make better, more informed compliance decisions.

Suricat helps you achieve compliance faster, smarter, and with confidence.

Our intelligent platform analyzes your quality system and identifies gaps before they become problems.

Key Capabilities

Comprehensive compliance intelligence built for medical device teams

Finding conflicting information

Detects inconsistencies across requirements, design specs, and validation records automatically.

Mapping documents to regulations

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

Highlighting potential risks

Surfaces compliance vulnerabilities before they become audit findings or regulatory issues.

Supporting design control & traceability

Creates complete traceability matrices linking requirements to risks, tests, and validations.

Comparing document versions

Tracks changes across document revisions and identifies compliance impact instantly.

Showing relationships between documents

Visualizes connections between SOPs, DHF, risk files, and validation protocols clearly.

Providing recommendations with evidence

Offers actionable suggestions backed by regulatory standards and industry best practices.

Clear Evidence•Full Traceability•Regulatory Context•No Black Boxes•
Clear Evidence•Full Traceability•Regulatory Context•No Black Boxes•

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.

Regulatory Confidence

Built to meet FDA, ISO, and EU MDR expectations with full traceability and documentation.

Expert Control

Your team reviews and approves every insight — Suricat provides intelligence, not automation.

Audit Readiness

Generate complete compliance packages in minutes, reducing preparation time from weeks to hours.

Risk Mitigation

Surface compliance vulnerabilities before they become findings or delay product launches.

Meet The Team

Built by Experts

Decades of combined experience in medical device compliance, quality systems, and regulatory strategy

professional male CEO executive in suit, confident leadership portrait, clean corporate headshot, modern office background, sharp focus

Mujeeb

CEO, Strategy & Product

Strategic vision and product leadership focused on solving real compliance challenges for medical device teams.

professional male CTO technology executive in business casual, confident tech leader portrait, clean corporate headshot, modern tech office background, sharp focus

Fahad

CTO, System Architecture

Technical architecture and engineering excellence ensuring secure, scalable compliance intelligence systems.

professional female regulatory affairs executive in business attire, confident leadership portrait, clean corporate headshot, modern office background, sharp focus

Kim

Regulatory Strategy

20+ years navigating FDA, ISO 13485, and EU MDR requirements for Class II and III medical devices.

professional male quality assurance executive in business attire, confident advisor portrait, clean corporate headshot, modern office background, sharp focus

Matt

Quality & Regulatory Advisor

Extensive quality systems expertise ensuring Suricat meets the highest standards of compliance rigor.

60+

Years Combined Experience

200+

Successful Audits Supported

100%

Human Oversight

How Suricat Works

Rules Engine

Captures regulatory requirements and checks documents against them with precision and consistency.

Advisory Layer

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

Built on a secure, enterprise-grade environment designed for medical device companies.

Who Uses Suricat

Trusted by compliance professionals across the medical device industry

Regulatory Affairs

Ensure submissions are complete, consistent, and aligned with global regulatory standards.

Quality Assurance & Quality Engineering

Maintain rigorous quality standards and identify gaps before they impact product release.

Design & Development

Streamline design control processes and maintain clear traceability from concept to validation.

Internal Audit & Compliance

Prepare for external audits with confidence and identify compliance risks proactively.

MedTech Consultants & Auditors

Deliver faster, more thorough assessments with intelligent compliance analysis tools.

Insights & Updates

Latest from Our Blog

Expert insights on regulatory compliance, quality systems, and the future of medical device development

professional medical device regulatory affairs team reviewing audit documentation in modern bright office, quality assurance professionals preparing compliance files, clean workspace with laptops and documents
Regulatory5 min read

Preparing for FDA Audits: A Complete Checklist

Essential steps to ensure your documentation is audit-ready and compliant with 21 CFR Part 820 requirements.

Read More
digital quality management system dashboard on computer screen, medical device compliance software interface with analytics, modern technology workspace, ISO 13485 certification documents
Quality Systems7 min read

ISO 13485:2016 Compliance in the AI Era

How intelligent compliance tools are transforming quality management while maintaining human oversight.

Read More
medical device engineering team reviewing design control traceability matrix on whiteboard, collaborative workspace with technical diagrams, requirements and testing documentation, professional development environment
Best Practices6 min read

Design Control Traceability Made Simple

Practical strategies for maintaining complete traceability from requirements to validation testing.

Read More
View All Articles
Common Questions

Frequently Asked Questions

Everything you need to know about Suricat's compliance intelligence platform

Suricat maps your documentation directly to FDA 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and IEC 62304 requirements. Our rules engine validates compliance in real-time while maintaining complete traceability and audit trails. Every recommendation includes regulatory context and evidence citations.

No. Suricat works alongside your existing systems (Greenlight Guru, MasterControl, Veeva Vault, etc.). We analyze your documents to provide intelligence and insights without requiring you to migrate data or change your current workflows. Think of us as an intelligent compliance layer that enhances your existing tools.

Most organizations are up and running within 2-4 weeks. We start with a pilot project on a specific product line or documentation set, demonstrate value quickly, then expand based on your priorities. Our team handles the technical setup while your experts focus on reviewing insights.

Suricat is built on enterprise-grade infrastructure with SOC 2 Type II compliance, end-to-end encryption, and role-based access controls. We offer cloud, private cloud, and on-premises deployment options. Our platform follows 21 CFR Part 11 requirements and includes comprehensive validation documentation to support your Computer System Validation (CSV) processes.

Yes. Suricat analyzes CAPA records, complaint files, and post-market surveillance data to identify patterns, assess impact on existing documentation, and ensure corrective actions are properly traced to root causes. This helps teams close CAPAs faster and demonstrate effectiveness during audits.

Every Suricat customer receives dedicated onboarding, role-based training, and ongoing support from our regulatory and quality experts. We provide comprehensive documentation, video tutorials, and a knowledge base. Our customer success team schedules regular check-ins to ensure you're maximizing value and staying current with regulatory changes.

Still have questions?

Contact our compliance experts to discuss your specific needs and how Suricat can help your team achieve audit readiness faster and with greater confidence.

Get in Touch

Bring Clarity to Compliance

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

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