Blue Goat Expands Medical Device Cybersecurity Services in Response to Increasing FDA Regulations

Medical device cybersecurity specialist Blue Goat Cyber ​​has announced that it is expanding its medical device cybersecurity offerings to meet growing regulatory needs. As FDA regulations become more stringent, the company aims to help customers keep up with the promise of fixed costs.

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

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

In response to increasing regulatory demands, Blue Goat Cyber ​​has expanded its offerings to provide medical device manufacturers with the expertise to navigate FDA regulations at a consistent cost.

Through a range of pre-launch services, Blue Goat Cyber ​​aims to help customers prepare their medical devices for market. This includes regulatory compliance support that provides guidance through FDA 510(k), De Novo, and PMA submission processes. This also includes risk management, such as risk assessment and development of mitigation strategies that are aligned with ISO 14971 and ISO/IEC 27001 standards. Through threat modeling, the team can identify and analyze potential security threats to the device, 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 the product development process. Finally, they ensure that devices can safely exchange information with other systems.

CEO Christian Espinosa states, “Our pre-launch services support manufacturers from development to regulatory submission. Fixed pricing provides predictability and peace of mind.”

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

Espinosa adds, “Our post-launch services keep devices secure and compliant over time. Our fixed-cost guarantee gives customers budget certainty and focus on innovation.”

About Blue Goat Cyber:

Blue Goat Cyber ​​is a disabled veteran-owned company specializing in cybersecurity solutions for the medical device industry. With a focus on pre- and post-market services, Blue Goat Cyber ​​ensures devices are secure, compliant, and resilient to evolving threats. For more information, visit https://bluegoatcyber.com/.

For more information about Blue Goat Cyber, please 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/

Edition number: 89134966

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