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Regulatory Support > Persistent Vulnerability Monitoring

Enduring Vigilance
for Your Technology

Long-term device safety requires long-term vigilance. Harbor Labs supports ongoing vulnerability monitoring with structured processes, customized tooling, and deep technical analysis to help clients meet postmarket expectations and respond swiftly to new threats.

Our Monitoring Capabilities

From threat monitoring to secure patching, Harbor Labs provides structured, regulator-ready processes to monitor and manage vulnerabilities throughout the product lifecycle.

Threat Surface Monitoring

Track and assess emerging threats that may impact components listed in the SBOM or HBOM.

CVE Monitoring % Triage

Continuously monitor known vulnerability databases and prioritize issues based on device exposure and impact.

Firmware & Component Watchlists

Flag known-vulnerable software or hardware elements for rapid reassessment as new threats emerge.

Secure Patch Strategy Development

Build responsive workflows to plan, validate, and document patch deployments postmarket.

Tooling & Process Support

Equip client teams with tailored scanning tools and repeatable workflows for scalable vulnerability management.

Regulatory Documentation & Reporting

Produce audit-ready records and justifications for detected vulnerabilities and remediation plans.

Smarter surveillance.
Safer systems.
Intelligent lifecycles.

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FIRMWAREIQ

Proprietary Firmware Intelligence —For Our Clients’ Strongest Defense

FirmwareIQ is Harbor Labs’ proprietary firmware analysis tool, designed to surface postmarket vulnerabilities across complex, embedded systems. Integrated into our service workflows, it gives our team deep visibility into firmware-level risks—enabling smarter remediation, stronger regulatory submissions, and long-term security posture improvements. Discover how FirmwareIQ and our cybersecurity expertise can strengthen your next submission.
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Purpose-Built for Medical Devices

Purpose-built to analyze the unique firmware architectures found in connected medical devices—ensuring alignment with real-world regulatory and operational demands.

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Software Bill of Materials (SBOM)

FirmwareIQ generates a high-fidelity SBOM from the target binary, optimized for regulatory submission and security research.

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Supports Regulatory Readiness

FirmwareIQ provides clear, categorized results with CVSS scores across OS, chipsets, libraries, cryptography, and networking for prioritized mitigation and FDA eSTAR integration.

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Faster, Clearer Threat Prioritization

You receive structured, expert-vetted findings that help identify and rank firmware vulnerabilities—accelerating the ability to make informed decisions during both premarket and postmarket phases.

Software Design & Development

Our in-house team designs and builds secure, efficient software across embedded, mobile, and cloud systems—always with compliance and cryptographic integrity in mind.

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Surgical Robotics System

Remediating a critical third-party vulnerability in surgical robotics, ensuring 510(k) readiness and safeguarding clinical operations from cybersecurity risks.

Read the Case Study

Looking for something else?

We also help teams with:

Compliance Assessment & Submission

We review and support your regulatory submissions with precision—identifying gaps, strengthening documentation, and aligning with evolving FDA expectations.

 

Security & Data Privacy

Design support and documentation to help meet regulatory expectations.

Hardware Testing

Interface validation, physical compromise evaluation, and teardown analysis.

Software & Firmware Testing

Vulnerability analysis, fuzz testing, and formal verification for medical codebases.

Let’s Strengthen Your Software’s Resilience