AI-powered compliance monitoring for MedTech, Pharma, and Biotech. Identify regulatory gaps and accelerate product delivery.
Trusted by Compliance Teams at Leading Life Sciences Companies
Regulatory and quality teams face increasing complexity managing documentation across DHF, DMR, risk management, and CAPA.
From chaos to continuous audit readiness.
We trust AI to find the gaps. Come build audit-ready systems.
No black boxes—just clear insights.
Automate gap analysis across your quality system documentation. Identify regulatory risks, ensure traceability, and maintain audit readiness with AI-powered insights.
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Quality Manager
Audit Readiness
Pending Reviews
Automatically detect inconsistencies across DHF, risk files, and validation records against regulatory standards.
Link requirements, risks, design outputs, and verification activities with automated traceability matrices.
Identifies inconsistencies across DHF, risk management files, and validation records against regulatory requirements.
Automated traceability matrices linking requirements, risks, design outputs, and verification activities.
Generate compliant documentation packages with complete evidence trails in minutes, not weeks.
Proactively identify and prioritize compliance risks before they become audit findings or regulatory issues.
Track changes across document revisions and identify compliance impact instantly with automated change detection.
Visualize connections between SOPs, DHF, risk files, and validation protocols with intelligent relationship mapping.
Provides actionable suggestions backed by regulatory standards and industry best practices for expert review and approval.
Maintains human oversight and expertise by providing intelligence, not automation—ensuring quality and regulatory integrity.
Comprehensive compliance intelligence built for medical device teams
Detects inconsistencies across requirements, design specs, and validation records automatically.
Links your quality system directly to FDA, ISO, and EU MDR requirements with precision.
Surfaces compliance vulnerabilities before they become audit findings or regulatory issues.
Creates complete traceability matrices linking requirements to risks, tests, and validations.
Tracks changes across document revisions and identifies compliance impact instantly.
Visualizes connections between SOPs, DHF, risk files, and validation protocols clearly.
Suricat helps teams catch issues early, prepare for audits faster, improve consistency, and strengthen compliance workflows — while keeping humans in charge.
Built to meet FDA, ISO, and EU MDR expectations with full traceability and documentation.
Your team reviews and approves every insight — Suricat provides intelligence, not automation.
Generate complete compliance packages in minutes, reducing preparation time from weeks to hours.
Surface compliance vulnerabilities before they become findings or delay product launches.
Suricat executives have helped grow the likes of Medtronic, Abbott, and Boston Scientific.
Combining precise regulatory logic with human-centric advisory intelligence.
Captures regulatory requirements and validates documents with precision, accuracy, and consistency.
Interprets context and meaning—while keeping final decisions in the hands of experts who understand your products best.
Trusted by compliance professionals across the medical device industry
Ensure submissions are complete, consistent, and aligned with global regulatory standards.
Maintain rigorous quality standards and identify gaps before they impact product release.
Streamline design control processes and maintain clear traceability from concept to validation.
Prepare for external audits with confidence and identify compliance risks proactively.
Deliver faster, more thorough assessments with intelligent compliance analysis tools.
Gain visibility into compliance health and reduce enterprise risk across all portfolios.
Bring structure and accountability to every compliance workflow and easily align documentation with regulatory standards.
Drive effective compliance reviews with customizable templates — choose from Suricat's library or build your own.
Track completion across your organization automatically. Never miss a periodic review or scheduled audit.
Drive accountability by linking documents to goals and ensuring follow-through with trackable action items.
Display past performance feedback within the platform, giving managers and employees a clear view of progress.
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.).
Our compliance experts are here to help
See how Suricat helps your team stay audit-ready without losing control.
