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 DevicesQMSR enforcement is now active. Are you inspection-ready?Check Your Readiness
Continuously evaluates cross-document alignment and surfaces inspection-defensible findings for earlier review.
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.
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.
Transform regulatory compliance through explainable intelligence that detects misalignment earlier, preserves human accountability, and enables inspection-ready decisions.
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.

Suricat operates as a neutral, read-only intelligence layer above existing systems of record. It does not replace validated infrastructure or alter system boundaries.
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.
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.
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 DevicesExplore how the Compliance Intelligence Layer can extend across additional regulated industries where documentation quality, evidence traceability, and regulatory oversight are equally critical.
Explore Industry ExpansionCompliance 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
Determine Fit
Will Suricat work on our documentation?
$0
90-day evaluation term
50 DOCUMENTS
Focused Evaluation
Active Documents
Core Platform
Support
Self-service support only.Knowledge base and guided onboarding included.
Start Free EvaluationOperational Validation
Validate Value
Can Suricat become part of our quality workflow?
$10,000
per year
250 DOCUMENTS
Single Device Program
Active Documents
Core Platform
Support
Email support and guided onboarding included.
Start PilotProduction Deployment
Operationalize
Can Suricat support ongoing compliance operations?
$25,000
per year
1,000 DOCUMENTS
Multiple Device Programs
Active Documents
Core Platform
Support
Priority email support.Accelerated response times.
Start FoundationEnterprise Scale
Scale & Govern
Can Suricat scale across the organization?
Custom
annual platform license
CUSTOM CAPACITY
Organization-Wide Deployment
Active Documents
Core Platform
Support
Shared Customer Success, Shared Technical Account Management, Escalation Management.
Contact SalesEvery 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 History | Limited | |||
| 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 Options | — | Optional | Optional | |
| Enterprise Governance | ||||
| Dedicated Suricat Cloud Environment | — | — | — | |
| Single Sign-On (SSO) | — | — | — | |
| Advanced Governance & Access Controls | — | — | — | |
| Service Level Agreement (SLA) | — | — | — | |
| Document Capacity Rollover | — | — | — | |
| Enterprise Extensions | ||||
| API Access | — | — | — | Optional |
| Custom Integrations | — | — | — | Optional |
| Dedicated Customer Success Manager | — | — | — | Optional |
| Technical Account Manager | — | — | — | Optional |