Summary: Blue Goat Cyber has expanded its pre- and post-market cybersecurity services for medical devices, helping manufacturers navigate stringent FDA regulations with comprehensive support from development through post-launch monitoring.

Key Takeaways:

  • Blue Goat Cyber’s pre-market services include regulatory compliance support, risk management, threat modeling, SBOM, and security by design.
  • Post-market services feature continuous monitoring, vulnerability management, incident management, and compliance maintenance, all offered with a fixed-cost guarantee for budgeting confidence.

Blue Goat Cyber, a provider of cybersecurity solutions for the medical device industry, has announced the expansion of its pre- and post-market medical device cybersecurity services.

Responding to Regulatory Changes

The expansion of pre- and post-market services is in direct response to increasingly stringent FDA requirements, according to the company. With growing regulatory demands, Blue Goat Cyber has enhanced its offerings to provide medical device manufacturers with the expertise needed to navigate FDA regulations on a fixed-cost guarantee.

Pre-Market Services

With a host of pre-market services, Blue Goat Cyber aims to help clients get their medical devices ready for launch. This includes regulatory compliance support, which provides guidance through FDA’s 510(k), De Novo, and PMA submission processes. It also includes risk management, such as risk assessments and developing mitigation strategies aligned with ISO 14971 and ISO/IEC 27001 standards.

With threat modeling, the team can identify and analyze potential threats to the device’s security, while their SBOM (Software Bill of Materials) provides a detailed inventory and analysis of all software components used in the device. The team incorporates OWASP Security by Design Principles to embed security measures throughout product development. Lastly, they ensure devices can securely exchange information with other systems.

Post-Market Services

Blue Goat Cyber also provides post-market services, supporting devices after launch with continuous monitoring using advanced threat intelligence in real-time, and vulnerability management through regular security assessments and updates. They also offer comprehensive support for managing cybersecurity incidents, including root cause analysis and remediation and compliance maintenance; ongoing support to ensure adherence to regulatory requirements, including documentation and reporting.

“Our pre-market services support manufacturers from development through regulatory submission,” said Christian Espinosa, Blue Goat Cyber CEO. “Our post-market services maintain device security and compliance over time. Our fixed-cost guarantee ensures clients can budget confidently and focus on innovation.”