Medical device cybersecurity specialist, Blue Goat Cyber, has announced that it is expanding its offering of medical device cybersecurity offerings to meet growing regulatory needs. As FDA regulations grow stricter, they aim to help clients keep up with a fixed-cost guarantee.

Cheyenne, Wyoming, United States - July 9, 2024 —

Having helped hundreds of manufacturers achieve FDA 510(k), De Novo, and PMA approvals, Blue Goat Cyber, a leading provider of cybersecurity solutions for the medical device industry has announced the expansion of its pre- and post-market medical device cybersecurity services. This is in direct response to a landscape of increasingly stringent FDA requirements.

In response to increasing regulatory requirements, Blue Goat Cyber has grown its offerings to provide medical device manufacturers with the expertise to navigate FDA regulations on a fixed-cost guarantee.

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.

CEO Christian Espinosa states, “Our pre-market services support manufacturers from development through regulatory submission. Fixed-cost pricing offers predictability and peace of mind.”

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.

Espinosa adds, “Our post-market services maintain device security and compliance over time. Our fixed-cost guarantee ensures clients can budget confidently and focus on innovation.”

About Blue Goat Cyber:

Blue Goat Cyber is a Service-Disabled Veteran-Owned Business specializing in cybersecurity solutions for the medical device industry. Focusing on pre-market and post-market services, Blue Goat Cyber ensures devices are secure, compliant, and resilient against evolving threats. For more information, visit https://bluegoatcyber.com/. 

For more information about Blue Goat Cyber use the contact details below:

Contact Info:
Name: Christian Espinosa
Email: Send Email
Organization: Blue Goat Cyber
Address: 1603 Capitol Ave Ste 415 PMB 45092, Cheyenne, WY, 82001
Phone: (844) 939-4628
Website: https://bluegoatcyber.com/

Release ID: 89134966

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