Suricat - Compliance Intelligence Platform Suricat - Compliance Intelligence Platform
compliance professional reviewing regulatory documentation
Compliance Intelligence Platform

Continuous Compliance Intelligence for Regulated Life Sciences

AI-powered compliance monitoring for MedTech, Pharma, and Biotech. Maintain audit readiness, identify regulatory gaps, and accelerate product delivery across FDA, ISO 13485, and EU MDR requirements.

FDA 21 CFR Part 11 Ready
ISO 13485:2016 Aligned
EU MDR Compliant

Trusted by Compliance Teams at Leading Life Sciences Companies

MedTech Co.
BioPharm Inc.
Device Systems
RegTech Labs

The Compliance Challenge

Regulatory and quality teams face increasing complexity managing documentation across DHF, DMR, risk management, CAPA, and post-market surveillance while maintaining continuous audit readiness.

Documentation Gaps

Inconsistencies between design controls, risk analyses, and validation protocols create audit vulnerabilities.

Manual Review Burden

Weeks spent preparing audit packages and cross-referencing requirements across multiple systems.

Traceability Gaps

Difficulty maintaining complete traceability from user needs through verification and validation.

Intelligent Compliance Monitoring

Suricat continuously analyzes your quality system documentation, identifies regulatory gaps, and provides audit-defensible insights—while keeping human experts in control.

Automated Gap Analysis

Identifies inconsistencies across DHF, risk management files, and validation records against regulatory requirements.

  • FDA 21 CFR Part 820 compliance mapping
  • ISO 13485 requirement traceability
  • EU MDR Annex I alignment verification

Complete Traceability

Automated traceability matrices linking requirements, risks, design outputs, and verification activities.

  • Design control traceability (IEC 62304)
  • Risk management integration (ISO 14971)
  • Verification and validation linkage

Audit-Ready Documentation

Generate compliant documentation packages with complete evidence trails in minutes, not weeks.

Compliance Risk Assessment

Proactively identify and prioritize compliance risks before they become audit findings or regulatory issues.

  • Early detection of non-conformances
  • Regulatory change impact analysis
  • Post-market surveillance monitoring

Version Control & Change Management

Track changes across document revisions and identify compliance impact instantly with automated change detection.

  • Change impact analysis
  • Version history tracking
  • Compliance impact assessment

Document Relationship Mapping

Visualize connections between SOPs, DHF, risk files, and validation protocols with intelligent relationship mapping.

  • Requirement-to-risk linkage
  • Design output verification
  • Compliance evidence trails

Human-in-the-Loop Recommendations

Provides actionable suggestions backed by regulatory standards and industry best practices for expert review and approval.

  • Compliance gap remediation plans
  • Regulatory change adaptation
  • Quality system improvement

Compliance Expertise Preservation

Maintains human oversight and expertise by providing intelligence, not automation—ensuring quality and regulatory integrity.

  • Expert decision-making
  • Compliance judgment
  • Regulatory interpretation

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.

Latest Insights

Compliance Insights

Stay informed on regulatory updates, compliance best practices, and industry trends

Regulatory•5 min read

FDA's Latest Guidance on AI/ML Medical Devices

Understanding the implications of FDA's new framework for AI-enabled medical devices and compliance requirements.

Read Article
Quality•7 min read

Streamlining Audit Preparation in 2024

Best practices for maintaining continuous audit readiness and reducing preparation time from weeks to days.

Read Article
EU MDR•6 min read

EU MDR Technical Documentation Updates

Key changes to technical documentation requirements and strategies for maintaining compliance across markets.

Read Article
Common Questions

Frequently Asked Questions

Get answers to common questions about Suricat's compliance intelligence platform

Suricat connects seamlessly with leading QMS platforms through secure APIs. We support integration with systems like Veeva Vault, MasterControl, Greenlight Guru, and custom enterprise solutions. Our platform can read and analyze documentation without requiring migration or changes to your existing workflows.
Yes. Suricat is designed with validation readiness in mind and includes comprehensive IQ/OQ/PQ documentation, audit trails, electronic signatures, and user access controls that meet FDA 21 CFR Part 11 requirements. We provide validation support packages to streamline your implementation process.
We offer flexible deployment options including cloud (AWS/Azure), private cloud, and on-premises installations. All deployments maintain the same security standards, including SOC 2 Type II certification, data encryption at rest and in transit, and role-based access controls.
Standard implementation takes 4-8 weeks, including system configuration, data integration, user training, and validation activities. Timeline varies based on your existing infrastructure, document volume, and validation requirements. We provide dedicated implementation support throughout the process.
No. Suricat is designed to augment your team's expertise, not replace it. The platform provides intelligence and identifies potential issues, but all decisions, approvals, and regulatory judgments remain with your qualified professionals. We believe in human-in-the-loop compliance.
Suricat analyzes all quality system documentation including DHF, DMR, risk management files, design controls, validation protocols, SOPs, CAPAs, complaint records, post-market surveillance reports, technical files, and regulatory submissions across multiple formats (PDF, Word, Excel, etc.).

Still have questions?

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

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