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Legacy Medical Device Cybersecurity Services

We help you close the cybersecurity gap to regulatory compliance with your legacy medical devices.

Fielded and end-of-life medical devices don’t get a free pass on cybersecurity. If your device runs on outdated software, uses an unsupported OS, or can’t be patched easily, you still need a practical way to reduce risk and maintain compliance—without breaking clinical workflows.

Blue Goat Cyber provides legacy medical device cybersecurity services designed for hard-to-patch, fielded, and end-of-life devices. We help you identify security gaps, prioritize what matters most, and maintain an ongoing postmarket program that supports FDA and EU MDR expectations—so you can protect patients, protect availability, and reduce regulatory risk.

medical device legacy cybersecurity

Get started: Schedule a Discovery Session to scope your device, constraints, and goals.

Who this service is for

This service is built for manufacturers who need to secure devices that are already deployed, including:

  • Fielded devices in hospitals, clinics, or home environments
  • End-of-life (EOL) devices still in use by customers
  • Devices with unsupported operating systems or third-party components
  • Products with limited update capability (or complex validation for updates)
  • Devices with known vulnerabilities or recurring customer security concerns

Common legacy medical device cybersecurity challenges

Legacy devices often face constraints that newer products don’t:

  • Outdated software and unsupported OS versions
  • Limited ability to patch without impacting performance or validation
  • Third-party dependencies that are difficult to inventory
  • Weak or inconsistent access control from earlier generations
  • Connectivity that expands risk (networked, remote access, wireless, APIs)
  • Limited visibility into security events (logging/monitoring gaps)

The goal isn’t to “make it perfect.” It’s to reduce risk intelligently and keep the device safe and supportable in the real world.

Our approach

1) Initial assessment and gap analysis

We start with a comprehensive evaluation to determine what’s in the device, what’s exposed, and what’s most likely to matter from a risk and compliance standpoint. The initial assessment typically includes:

  • Static Application Security Testing (SAST)
    Source code analysis to identify security weaknesses in the device’s software.
  • Software Bill of Materials (SBOM)
    We generate a detailed SBOM to inventory software components (including third-party and open-source) and highlight software of unknown provenance (SOUP) and other risk-driving dependencies.
  • Penetration Testing (device/system-appropriate)
    We simulate real-world attacks to evaluate how the device and its interfaces withstand targeted threats and misuse scenarios.

2) Deliverables: gap report + prioritized remediation roadmap

You receive a clear, actionable report that includes:

  • A gap analysis of security deficiencies and exposure points
  • A prioritized remediation roadmap (what to fix first, what can wait, and why)
  • Practical recommendations that balance security, device functionality, and regulatory expectations

This roadmap is designed to help your team focus its efforts where they reduce risk the fastest.

3) Ongoing postmarket cybersecurity management (optional contract)

After the assessment and initial remediation phase, Blue Goat Cyber offers an ongoing postmarket cybersecurity management contract to keep legacy devices protected throughout their operational lifecycle. This can include:

  • Regular security monitoring and threat detection
    Continuous monitoring for emerging threats and vulnerabilities across software and relevant environments.
  • Patch management and vulnerability remediation support
    Guidance on updates and security fixes, including prioritization and deployment planning.
  • Compliance management support
    Assistance maintaining alignment with regulatory requirements (including FDA expectations and applicable EU MDR/MDCG cybersecurity expectations).
  • Incident response and recovery planning
    Support to minimize downtime, restore functionality, and produce clear documentation if a cybersecurity event occurs.

Compensating controls for hard-to-patch legacy devices

  • When patching isn’t immediate (or isn’t feasible), risk reduction often depends on practical compensating controls. Your roadmap may include controls such as:
  • Network segmentation and deployment hardening guidance
  • Access restrictions (reducing unnecessary services/ports and limiting remote access paths)
  • Account/credential improvements and privilege controls where feasible
  • Monitoring and detection improvements to increase response speed
  • Configuration changes that reduce exposure without breaking functionality
  • The goal is to reduce exposure now, while you plan longer-term remediation.

Typical timeline

  • Most initial assessments are completed in 4–6 weeks, depending on device complexity, access, and scope. You’ll get a clear timeline and milestones after the Discovery Session.

What we need from your team to get started

  • To move quickly, we typically request:
  • Product versions in the field (and what’s currently supported)
  • Architecture diagrams and key interfaces (device/app/cloud/update paths)
  • Access method for testing (lab unit, builds, credentials, test environment)
  • Source code access for SAST (when applicable)
  • Any existing risk documentation or prior test results (if available)
  • If you don’t have everything ready, that’s okay—we’ll identify the most efficient path during discovery.

Legacy devices don’t have to remain your biggest cybersecurity liability. With the right assessment, a prioritized remediation roadmap, and practical compensating controls, you can reduce real-world risk—even when patching isn’t simple.

If you’re supporting fielded or end-of-life devices, the fastest path forward is a focused discovery call. We’ll scope your device ecosystem, constraints, and goals, then recommend the most efficient plan to improve security and maintain postmarket readiness.

Schedule your Legacy Device Discovery Session to get started.

Get Started Today

Legacy Medical Device Cybersecurity FAQs

Please schedule a 30-minute Discovery Session with us so we can best understand your objectives.

The initial assessment includes Static Application Security Testing (SAST) to analyze source code vulnerabilities, a Software Bill of Materials (SBOM) for identifying third-party and open-source components, and comprehensive penetration testing to simulate real-world cyberattacks. This assessment provides a gap analysis and a roadmap for remediation.

An SBOM provides a detailed inventory of all software components, including third-party libraries and Software of Unknown Provenance (SOUP). This transparency helps identify outdated or unsupported software that could introduce vulnerabilities, ensuring all components meet modern security standards.

The gap analysis identifies existing vulnerabilities and security deficiencies within the legacy device's software and hardware, providing a prioritized roadmap for addressing these issues. This allows your organization to allocate resources effectively and ensures that critical vulnerabilities are addressed promptly.

Postmarket management ensures that your legacy medical devices remain secure after the initial assessment. This includes regular monitoring, patch management, and support for maintaining compliance with regulatory requirements, helping to keep devices secure throughout their lifecycle.

Penetration tests are conducted on a regular basis or as required by emerging threats. The frequency is tailored based on the specific risks and the criticality of the device, ensuring that vulnerabilities are identified and addressed promptly.

If a vulnerability is discovered, our team will provide immediate guidance for remediation. This may involve deploying patches, updating software, or implementing additional security controls. We work closely with your team to ensure that corrective actions are implemented without disrupting device functionality.

Our services are designed to meet the cybersecurity requirements set by the FDA for medical devices and the EU Medical Device Regulation (MDR). We ensure that your legacy devices remain compliant through ongoing risk management, documentation, and adherence to cybersecurity best practices​​.

Our services cover a wide range of legacy medical devices, including those with embedded software, networked devices, and unsupported or outdated operating systems. We customize our approach to address each device's specific security needs and regulatory considerations.

Yes, as part of our postmarket management service, we assist with preparing documentation required for regulatory reporting during a cybersecurity incident. This includes incident reports, updates to the postmarket surveillance plan, and support with field safety corrective actions (FSCA).

The time required for the initial assessment varies depending on the complexity of the device and its software. However, most assessments are completed within 4-6 weeks. The gap analysis report, including a detailed roadmap for remediation, is delivered shortly after that to ensure timely action on identified vulnerabilities.

Schedule Your Legacy Medical Device Discovery Session