QMSR enforcement is now active. Are you inspection-ready?Check Your Readiness

The Sentinel for
ComplianceIntelligence

Continuously evaluates cross-document alignment and surfaces inspection-defensible findings for earlier review.

Cost of Misalignment

Compliance Misalignment Does Not Announce Itself. These Are Its Consequences

Misalignment often remains hidden until an inspection, CAPA, or recall exposes it. By then, the impact is already measurable. The data below reflects the realities medical device manufacturers face under QMSR and ISO 13485.

FDA Warning Letters

44 Warning Letters

Indicates significant quality system gaps that can escalate.

CAPA Deficiencies

~50% of Device Firms

Face CAPA deficiencies, a leading driver of inspection findings.

Recall Exposure

$10M–$50M+

Major recalls can create significant remediation and operational burden.

Recall Resolution Time

Up to 2 Years

Serious medical device recalls can take years to fully resolve.

Training Compliance Gaps

67% of Audit Findings

Involve training deficiencies or outdated records.

Manual Audit Preparation

Weeks of Preparation

Teams still manually assemble evidence, increasing effort and risk of oversight.

Check Your Readiness

Learn how Suricat approaches compliance intelligence

Why Suricat

The Systems Are in Place. The Alignment Between Them is Not.

Requirements change. Documents evolve. Evidence accumulates. Over time, demonstrating that critical quality and regulatory documentation remains aligned becomes increasingly difficult.

Continuous Alignment

Detects misalignment before inspection.

Preserves human accountability.

Enables inspection-ready decisions.

Suricat's Mission

Transform regulatory compliance through explainable intelligence that detects misalignment earlier, preserves human accountability, and enables inspection-ready decisions.

Platform

The Systems Remain. The Intelligence Layer Sits Above Them.

Suricat is a read-only Compliance Intelligence Layer that continuously evaluates alignment across quality and regulatory documentation without changing the systems organizations already depend on.

Intelligence Layer

Intelligence Layer

Suricat operates as a neutral, read-only intelligence layer above existing systems of record. It does not replace validated infrastructure or alter system boundaries.

Solutions

No Single Document Tells The Full Story.
The Connections Between Them Do.

Understand how the Compliance Intelligence Layer helps Quality and Regulatory teams identify potential concerns earlier, understand their impact, and maintain greater confidence across compliance-critical documentation.

Documentation Confidence

Confidence In The Evidence

Understand whether the evidence behind a quality or regulatory decision is complete, traceable, and sufficient.

Inspection-Defensible Findings

Defensible Conclusions

Understand how a finding connects to the evidence, records, and activities that produced it.

Inspection Readiness

Readiness Before Preparation

Understand the current readiness of the quality system at any time, not only once preparation begins.

Continuous Compliance

Visibility Between Reviews

Maintain awareness of compliance posture in the periods between audits, inspections, and management reviews.

Change Impact Assessment

Impact Beyond The Change

Understand how a change relates to the documentation, processes, and obligations it may affect.

Documentation Alignment

Alignment Across Documentation

Identify where related procedures, records, and supporting evidence may no longer be consistent.

Check Your Readiness

Explore each solution to see how the Compliance Intelligence Layer applies it.

Industries

Built For Regulated Industries.
Starting With Medical Devices.

Medical device manufacturers operate within one of the world's most demanding documentation environments. Suricat begins here because if the Compliance Intelligence Layer can earn trust where documentation complexity and regulatory expectations are highest, it can naturally extend across other regulated industries.

Medical Devices

Learn why medical devices represent the first implementation of the Compliance Intelligence Layer and how Suricat helps Quality and Regulatory teams maintain documentation alignment and inspection readiness.

Explore Medical Devices

Industry Expansion

Explore how the Compliance Intelligence Layer can extend across additional regulated industries where documentation quality, evidence traceability, and regulatory oversight are equally critical.

Explore Industry Expansion
Pricing

The Scope Lives in the Documentation.
Not the Seat Count.

Compliance complexity is reflected in documentation, not headcount. Every Suricat subscription combines an Annual Platform License with a defined Document Capacity, allowing Quality and Regulatory teams to collaborate without per-seat licensing constraints.

Documents may be evaluated across all six Compliance Intelligence solutions without additional consumption charges.

Evaluation

Evaluate

Determine Fit

Will Suricat work on our documentation?

$0

90-day evaluation term

50 DOCUMENTS

Focused Evaluation

Active Documents

  • 1 Organization
  • 1 User
  • 1 Product Family
  • 90-Day Evaluation Term

Core Platform

  • All Six Compliance Intelligence Solutions
  • Self-service evaluation workspace
  • Evidence navigation
  • Guided onboarding
  • Knowledge base

Support

Self-service support only.Knowledge base and guided onboarding included.

Start Free Evaluation

Operational Validation

Pilot

Validate Value

Can Suricat become part of our quality workflow?

$10,000

per year

250 DOCUMENTS

Single Device Program

Active Documents

  • 1 Organization
  • Up to 2 Users
  • 1 Product Family
  • 1 Regulatory Framework
  • Twelve-Month Subscription

Core Platform

  • All Six Compliance Intelligence Solutions
  • Production workspace
  • Continuous monitoring
  • Report export
  • Saved analysis history

Support

Email support and guided onboarding included.

Start Pilot

Enterprise Scale

Enterprise

Scale & Govern

Can Suricat scale across the organization?

Custom

annual platform license

CUSTOM CAPACITY

Organization-Wide Deployment

Active Documents

  • Unlimited Users
  • Custom Product Families
  • Custom Regulatory Frameworks
  • Custom Subscription Term

Core Platform

  • Dedicated Suricat Cloud environment
  • Custom retention policies
  • Document capacity rollover
  • Single sign-on and governance
  • Advanced RBAC and audit logging
  • Contracted SLA

Support

Shared Customer Success, Shared Technical Account Management, Escalation Management.

Contact Sales
Published annual pricingTwelve-month termsNo per-seat fees
Compare Subscription Options

The Intelligence Remains The Same. The Operational Scope Expands.

Every tier includes all six Compliance Intelligence solutions. Document capacity, collaboration, governance, support, and deployment options expand as your compliance program grows.

Capability
EvaluateDetermine Fit
PilotValidate Value
Most PopularFoundationOperationalize
EnterpriseScale & Govern
Core Platform
All Six Compliance Intelligence Solutions
Customer Documentation
Analysis HistoryLimited
Email Support
Continuous Monitoring
Export Findings & Reports
Shared SaaS Environment
Guided SaaS Environment
Collaboration & Operations
Team Collaboration
Shared Workspaces
Priority Email Support
Extended Data Retention OptionsOptionalOptional
Enterprise Governance
Dedicated Suricat Cloud Environment
Single Sign-On (SSO)
Advanced Governance & Access Controls
Service Level Agreement (SLA)
Document Capacity Rollover
Enterprise Extensions
API AccessOptional
Custom IntegrationsOptional
Dedicated Customer Success ManagerOptional
Technical Account ManagerOptional
IncludedNot includedLimitedLimited AccessOptionalAvailable as Add-On