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

The Sentinel for
Compliance Intelligence

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 IS013485.

FDA Warning Letters

44 Warning Letters

Indicates significant quality system gaps that can escalate.

Source: FDA FY2025 Enforcement Data

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CAPA Deficiencies

~50% of Device Firms

Face CAPA deficiencies, a leading driver of inspection findings.

Source: FDA Inspection Observation Reports

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Recall Exposure

$10M–$50M+

Major recalls can create significant remediation and operational burden.

Source: FDA Class I Recall Cost Analysis

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Recall Resolution Time

Up to 2 Years

Serious medical device recalls can take years to fully resolve.

Source: FDA Medical Device Recall Database

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Training Compliance Gaps

67% of Audit Findings

Involve training deficiencies or outdated records.

Source: FDA Inspection Observation Reports

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Manual Audit Preparation

Weeks of Preparation

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

Source: FDA Quality System Regulation

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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.

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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.

The Intelligence Layer

The 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.

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Built for highly regulated industries

Compliance intelligence wherever documentation alignment is mission-critical

Built for the compliance complexity of highly regulated industries — not adapted from generic tools.

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Medical Devices

FDA design controls, 21 CFR Part 820, ISO 13485, and the full DHF-to-submission compliance stack

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Biotechnology

Advanced therapy and biologics regulatory intelligence

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Pharmaceuticals and Biopharma

Comprehensive drug development and manufacturing compliance

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Clinical Trials

Trial master file and protocol alignment compliance

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