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Legacy Medical Device Cybersecurity Services

We help you close the cybersecurity gap to regulatory compliance with your legacy medical devices.
Schedule Your Legacy Medical Device Discovery Session
Blue Goat Cyber helped us with a roadmap to secure our fielded legacy products. We are having them work with the rest of our medical device portfolio as well.
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Troy Baumgarten
CEO

Steps to Schedule Legacy Medical Device Cybersecurity Services:

1. Schedule a 30-minute Discovery Session

2. We determine IF and HOW we can help

3. We provide a Tailored Proposal

4. Together, we review the Proposal

FDA Cybersecurity Deficiency Response

Legacy Medical Device Cybersecurity Support​

Blue Goat Cyber provides tailored cybersecurity services designed specifically for legacy medical devices. These devices often have unique challenges, including outdated software, unsupported systems, and heightened vulnerability to cyber threats. Our services ensure that these devices meet modern security standards and comply with regulatory requirements, maintaining safety, integrity, and continuity of patient care.

Initial Assessment and Gap Analysis: Our legacy device service begins with a comprehensive evaluation, including:

  • Static Application Security Testing (SAST): We conduct a deep analysis of the source code to identify potential vulnerabilities in the software of the device, ensuring that even legacy codebases are thoroughly reviewed for security risks.
  • Software Bill of Materials (SBOM): We generate a detailed SBOM to map all software components, including third-party or open-source libraries. This ensures complete transparency of components and identifies any software of unknown provenance (SOUP).
  • Penetration Testing: Simulating real-world attacks, we assess the device’s ability to withstand targeted cyber threats, uncovering vulnerabilities that malicious actors could exploit.

Deliverables: The initial assessment results in a detailed gap analysis report outlining security deficiencies and providing a prioritized remediation roadmap. This roadmap helps manufacturers understand where to focus their efforts, balancing security improvements with device functionality and regulatory compliance​​.

Postmarket Management Contract: Following the gap analysis and initial remediation phase, Blue Goat Cyber offers a postmarket cybersecurity management contract. This ongoing service ensures the continuous security of your legacy devices throughout their operational lifecycle. The contract includes:

  • Regular Security Monitoring and Threat Detection: Continuous monitoring for emerging threats and vulnerabilities in both software and network environments.
  • Patch Management and Vulnerability Remediation: Ongoing support for applying security patches and updates, addressing issues identified through vulnerability assessments.
  • Compliance Management: Assistance in maintaining compliance with regulatory requirements such as FDA guidelines and the Medical Device Coordination Group (MDCG) standards​.
  • Incident Response and Recovery Planning: In case of a security breach, we provide expert support for incident response, minimizing downtime and restoring device functionality.

With this comprehensive approach, Blue Goat Cyber ensures that legacy medical devices remain secure against current cyber threats and continue to meet evolving regulatory demands, protecting patient safety and data integrity throughout the device’s lifecycle.

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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.

Our purpose is simple – to secure your product and business from cybercriminals.

The number of cybersecurity incidents continues to climb. The variety of attacks continues to grow. It is no longer a question of if you will have a cyber event.

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