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Regulatory Support > Persistent Vulnerability Monitoring

Continuous Threat

Monitoring &

Management Service

Long-term device safety requires long-term vigilance. With FirmwareIQ™, 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.

FirmwareIQ Monitoring Capabilities

Eliminate vulnerability blind spots while exceeding regulatory requirements for postmarket surveillance with Harbor Labs’ FirmwareIQ monitoring service.  FirmwareIQ provides comprehensive vulnerability monitoring of the entire attack surface of a medical system, to include software/firmware, hardware components, and connected third-party peripherals. More than just a vulnerability report, FirmwareIQ is backed by the Harbor Labs cyberengineering staff, providing as-needed consulting in response to postmarket findings.

Multi-faceted Persistent Monitoring

FirmwareIQ continuously tracks your system’s SBOM, HBOM, and 3BOM to provide full visibility into your software and hardware components.

Automated Vulnerability Reporting

FirmwareIQ delivers monthly comprehensive vulnerability reports, giving your team actionable intelligence to stay ahead of emerging threats without manual effort.

Real-Time Alerts

When high or critical vulnerabilities appear, FirmwareIQ issues immediate notifications, enabling you to respond quickly and mitigate risk before it impacts clinical operations.

Smarter surveillance.
Safer systems.
Intelligent lifecycles.

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FIRMWAREIQ

Expert Cyber Engineering Support—Every Step of the Way

Harbor Labs’ experienced cyber engineers extend your team’s capabilities with hands-on support across the full vulnerability lifecycle. From validating findings and assessing risk to guiding remediation strategies and coordinating responsible disclosure, we provide the technical depth and regulatory awareness needed to safeguard your systems in clinical uses.

        Contact Harbor Labs for a customized annual FirmwareIQ subscription quote tailored to the size and complexity of your target system.

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Validation & Risk Assessment

Harbor Labs’ cyber engineers validate findings against real-world attack scenarios and regulatory expectations. Our risk assessments quantify potential harm and prioritize remediation, ensuring you have clarity on where to act first.

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Remediation & Patch Strategy

We help design and implement effective patch strategies tailored to your system architecture and compliance requirements. From short-term mitigations to long-term fixes, we ensure your remediation plan is both practical and ready for regulatory review.

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Responsible Disclosure

Our team supports responsible communication of discovered vulnerabilities to stakeholders, partners, and regulators. We help you build a disclosure pathway that balances transparency, security, and trust across your ecosystem.

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