Clear insights across your quality and regulatory documents without taking control away from your experts.
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.
Automatically detects inconsistencies between your design history file and regulatory requirements.
Link requirements to tests and hazards effortlessly, creating an unbreakable chain of evidence.
Generate complete documentation packages in seconds, significantly reducing audit preparation time.
Critical discrepancies between design files, risk assessments, and validation reports.
Weeks spent scrambling to gather evidence and explain document gaps.
Manual cross-referencing delays approvals and increases compliance risk.
Human oversight in complex documentation can lead to costly non-conformances.
Experts spend time hunting for information instead of making strategic decisions.
DHF-2023-45
Missing traceability link
Risk-Analysis-v3
Inconsistent severity ratings
Validation-Protocol
Outdated regulatory reference
SOP-QA-012
Conflicting procedure steps
Intelligent compliance analytics that works alongside your team.
Automatically ingests DHF files, risk analyses, and validation protocols to build a comprehensive understanding.
Identifies inconsistencies between requirements, design outputs, verification records, and regulations standards.
Surfaces compliance vulnerabilities before they become audit findings, giving your team time to address issues proactively.
Prioritizes compliance issues based on risk, regulatory importance, and impact on product safety and effectiveness.
Generates audit-ready documentation packages in seconds, cutting preparation time from weeks to minutes.
Provides clear, data-driven insights that help teams make better, more informed compliance decisions.
Our intelligent platform analyzes your quality system and identifies gaps before they become problems.
Comprehensive compliance intelligence built for medical device teams.
Detects inconsistencies across DHF, risk files, and validation documents.
Automatically links your documentation to FDA, ISO, and EU MDR requirements.
Proactive identification of compliance gaps before audits.
Complete traceability matrix from requirements to verification.
Track changes and ensure version control compliance.
Visual mapping of document dependencies and connections.
Captures regulatory requirements and checks documents against them with precision and consistency.
Interprets context and meaning — while leaving decisions to humans. Intelligence, not automation.
Built on a secure, enterprise-grade environment designed for medical device companies.
Streamline submission prep and regulatory intelligence.
Maintain compliance and reduce audit findings.
Accelerate product development with better compliance insights.
Suricat helps teams catch issues early, prepare for audits faster, improve consistency, and strengthen compliance workflows — while keeping humans in charge.
Faster Audit Prep
Issue Detection Rate
Time Savings
Human Control
Our founding team brings decades of combined experience in medical device compliance, quality systems, and regulatory strategy.
CEO & Strategy
Product vision and medical device industry expertise
CTO & Engineering
System architecture and enterprise software development
Regulatory Strategy
20+ years in FDA submissions and global regulatory affairs
Quality & Compliance
ISO 13485 auditor and quality system implementation expert
Expert guidance on medical device compliance, regulatory trends, and quality management best practices.
Essential documentation requirements and common pitfalls to avoid when preparing your 510(k) submission package.
Read More
Strategic approaches to streamline your ISO 13485 audit preparation and ensure continuous compliance.
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Understanding the enhanced documentation requirements under EU MDR 2017/745 and how to maintain compliance.
Read MoreEverything you need to know about Suricat and compliance intelligence.
Suricat seamlessly integrates with popular QMS platforms through secure APIs and standard file formats. We support direct connections to systems like Greenlight Guru, MasterControl, and Arena, as well as document imports from SharePoint, Google Drive, and local file systems. Our platform maintains full traceability while working alongside your existing workflows.
Yes, Suricat is built with 21 CFR Part 11 compliance at its core. We maintain complete audit trails, electronic signatures, user authentication, and data integrity controls. Our infrastructure is validated and regularly audited to ensure ongoing compliance with FDA electronic records requirements.
Suricat analyzes all critical quality and regulatory documents including Design History Files (DHF), risk management files (ISO 14971), validation protocols and reports, Standard Operating Procedures (SOPs), technical files for EU MDR, regulatory submissions, and traceability matrices. We support PDF, Word, Excel, and other common formats.
Most implementations are completed within 2-4 weeks. This includes system configuration, document ingestion, team training, and validation. Our implementation team works closely with your quality and regulatory staff to ensure a smooth transition with minimal disruption to ongoing operations.
No. Suricat is designed to augment your team's capabilities, not replace them. We provide intelligent insights, gap analysis, and recommendations, but all final decisions remain with your qualified personnel. Our platform emphasizes transparency and human oversight, ensuring your experts maintain full control over compliance decisions.
Suricat employs enterprise-grade security including end-to-end encryption, SOC 2 Type II compliance, role-based access controls, and regular security audits. All data is hosted in secure, HIPAA-compliant data centers with redundancy and disaster recovery protocols. We also offer on-premise deployment options for organizations with specific data residency requirements.
"Suricat reduced our audit preparation time from 3 weeks to 2 days. The traceability matrix alone saved us hundreds of hours."
Sarah Chen
VP Quality, MedTech Innovations
"The intelligent gap analysis caught a critical inconsistency in our risk assessment that we would have missed otherwise. This has already prevented a potential non-conformance."
David Kim
Quality Director, MedTech Solutions
"Suricat's automated traceability has completely transformed our documentation process. We now have a single source of truth that's always up-to-date and fully compliant."
Lisa Rodriguez
Regulatory Affairs Manager, HealthTech Innovations