Blue Goat Cyber, a medical device cybersecurity specialist, has announced its success in helping hundreds of manufacturers follow cybersecurity regulations. Amidst growing FDA stringency, they offer an expanded range of services to help even more in the industry.
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Having worked with manufacturers in the medical device industry for years, cybersecurity solutions provider, Blue Goat Cyber, is proud to announce that it has helped hundreds of manufacturers reach compliance, and aims to help more as it expands its range of services. With their medical device cybersecurity services on a fixed-cost guarantee, Blue Goat Cyber has ensured successful results with predictable expenses, achieving FDA 510(k), De Novo, and PMA approvals for their clients' devices.
As growing regulatory requirements put the industry under more pressure, Blue Goat Cyber has decided to expand its services to better help medical device manufacturers navigate stricter FDA regulations.
Pre-Market Services:
- Regulatory Compliance Support: Guidance through FDA's 510(k), De Novo, and PMA submission processes.
- Risk Management: Conducting risk assessments and developing mitigation strategies aligned with ISO 14971 and ISO/IEC 27001 standards.
- Threat Modeling: Identifying and analyzing potential threats to the device's security.
- SBOM (Software Bill of Materials): Detailed inventory and analysis of all software components used in the device.
- Secure Design: Integrating OWASP Security by Design Principles to embed security measures throughout product development.
- Interoperability Assurance: Ensuring 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.”
Post-Market Services:
- Continuous Monitoring: Using advanced threat intelligence to monitor devices in real-time and respond to threats.
- Vulnerability Management: Regular security assessments and updates to address new vulnerabilities.
- Incident Response: Comprehensive support for managing cybersecurity incidents, including root cause analysis and remediation.
- 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:
As a Service-Disabled Veteran-Owned Business, Blue Goat Cyber understands the importance of ensuring that effective medical devices can make it to market and provides cybersecurity solutions for just that reason. With the above services, they can help manufacturers ensure the security, compliance, and resilience of their devices against an ever-growing landscape of evolving threats.
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: 89134489
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