Comprehensive Cybersecurity Solutions to Ensure FDA Premarket Success

From secure design consulting to SBOM management and penetration testing, we provide tailored solutions that protect your devices, ensure compliance, and streamline your FDA submission.

Premarket Cybersecurity: Essential for FDA Approval and Patient Safety

For medical device manufacturers, premarket cybersecurity is critical to regulatory success. With the FDA’s latest guidance and global frameworks like AAMI TIR57, ensuring your device meets stringent cybersecurity requirements is no longer optional—it’s essential.

Failing to address these standards can result in:

Regulatory Delays: Non-compliant submissions lead to deficiency letters and costly resubmissions.
Patient Safety Risks: Vulnerabilities in device software or connectivity could compromise lives.
Reputational Damage: Insecure devices erode trust with regulators, healthcare providers, and patients.

At Blue Goat Cyber, we provide comprehensive premarket cybersecurity services to help you navigate these challenges with confidence, ensuring your devices are secure, compliant, and ready for approval.

Start your FDA submission with confidence. Schedule a free Discovery Session today.

Tailored Solutions for Every Stage of Your Premarket Submission

We offer a full suite of services to address every cybersecurity requirement for FDA approval. Our solutions align with the latest FDA guidance, AAMI TIR57, and global security standards to ensure your devices meet regulatory expectations.

Secure MedTech Product Design Consulting

Build cybersecurity into your device design from the start.
Identify potential vulnerabilities early and develop a secure-by-design framework.
Align your process with FDA guidelines, IEC 62304, ISO 14971, and AAMI TIR57. [Learn More →]

SBOM (Software Bill of Materials) Management

Create and maintain a detailed SBOM to track vulnerabilities in third-party and open-source software.
Ensure compliance with FDA and AAMI TIR57 requirements for supply chain security.
Monitor and update your SBOM throughout development to address emerging risks. [Learn More →]

Penetration Testing

Perform rigorous manual and automated testing to identify vulnerabilities in software, hardware, and network interfaces.
Simulate real-world attack scenarios to assess and improve your device’s resilience.
Provide FDA-compliant reports to demonstrate your device’s security. [Learn More →]

Threat Tree Development

Map out potential risks to your device using a structured threat tree methodology.
Prioritize vulnerabilities and document mitigation strategies that meet FDA requirements and align with AAMI TIR57.
Support secure-by-design principles to enhance patient safety and compliance. [Learn More →]

Static Application Security Testing (SAST)

Analyze your source code for vulnerabilities early in the development lifecycle.
Ensure secure coding practices that align with FDA and AAMI TIR57 cybersecurity standards.
Continuously monitor and test updates to prevent new vulnerabilities from entering your codebase. [Learn More →]

Full-Service Cybersecurity Consulting

Develop a comprehensive cybersecurity strategy tailored to your device’s unique architecture and use case.
Align your processes with FDA guidance, AAMI TIR57, IEC 62304, and ISO 14971.
Provide end-to-end support to ensure your device is fully compliant and FDA-ready. [Learn More →]

FDA Deficiency Response Services

Quickly address cybersecurity deficiencies identified in your 510(k) or PMA submissions.
Deliver actionable solutions and updated documentation to get your submission back on track.
Minimize delays and ensure your device meets FDA standards. [Learn More →]

Your Trusted Partner for Premarket Cybersecurity

Specialized Expertise

A decade of experience dedicated to medical device cybersecurity.

Regulatory Alignment

All services align with FDA guidance, AAMI TIR57, IEC 62304, and ISO 14971.

Tailored Solutions

Every service is customized to meet your device’s unique needs and submission goals.

Proven Results

A 100% success rate in helping manufacturers achieve FDA approval without cybersecurity-related delays.

Comprehensive Support

From secure design consulting to deficiency response, we provide end-to-end support for your premarket needs.

Trusted by Leading Medical Device Manufacturers

“Blue Goat Cyber’s comprehensive services made our FDA submission process seamless. Their penetration testing and documentation met every requirement, and our approval came faster than expected.”
— Director of Regulatory Affairs, Medical Device Manufacturer

“After receiving a deficiency letter from the FDA, Blue Goat Cyber stepped in and quickly resolved the issues. Their expertise in AAMI TIR57 compliance and FDA requirements was invaluable.”
— VP of Quality Assurance, IoT Medical Device Company

Join the hundreds of manufacturers we’ve helped achieve FDA success. Schedule your free Discovery Session today.

A Clear Path to Premarket Cybersecurity Success

Discovery Session: We start by understanding your device, its architecture, and your submission goals.

Tailored Cybersecurity Plan: Our experts develop a customized plan that includes testing, threat modeling, and regulatory documentation.

Comprehensive Testing and Reporting: We conduct rigorous evaluations and provide detailed, FDA-compliant reports for your submission.

Submission and Support: If deficiencies arise, we respond quickly to keep your approval process on track.

Get Started Today:

Schedule a free Discovery Session.
Receive tailored guidance for your device’s submission.
Achieve FDA approval with guaranteed results.