FDA-Compliant Penetration Testing Tailored for Medical Devices

We help medical device manufacturers meet premarket cybersecurity requirements with expert penetration testing that aligns with FDA guidelines and ensures patient safety.

Traditional Pen Testing Falls Short for Medical Devices

Many penetration testing companies lack the specialized knowledge required to meet the unique needs of medical device manufacturers. They focus on generic testing methods that may not align with FDA premarket submission requirements or adequately address the risks posed to patients. This gap can lead to:

  • Incomplete Testing: Missed vulnerabilities specific to embedded systems, IoT devices, or medical applications.
  • Non-Compliant Reports: Documentation that doesn’t satisfy FDA requirements, causing costly delays.
  • Increased Risk: Overlooking vulnerabilities that could compromise device functionality and patient safety.

When it comes to premarket submissions, you need a partner who understands the nuances of FDA cybersecurity guidance and the high stakes of protecting both patients and your reputation.

Need FDA-compliant pen testing? Schedule a free Discovery Session today.

medical device cybersecurity

Why Medical Device Manufacturers Choose Blue Goat Cyber for Penetration Testing

At Blue Goat Cyber, medical device cybersecurity isn’t just part of what we do—it’s our sole focus. Unlike traditional penetration testing companies, we understand the intricacies of FDA guidelines, AAMI TIR57, IEC 62304, and ISO 14971

Our tailored approach ensures your devices meet premarket submission requirements while addressing patient safety and regulatory compliance.

How We’re Different

FDA-Ready Documentation

We provide detailed, submission-ready reports tailored to the latest FDA cybersecurity guidance, ensuring a smooth review process.

Medical Device Expertise

Our team has over a decade of experience working exclusively with medical devices, from diagnostic tools to robotic surgical systems.

Beyond Automated Testing

We don’t just rely on automated tools. We perform manual logic testing to uncover vulnerabilities unique to medical devices that automated scanners often miss.

Focus on Patient Safety

We understand the high stakes of medical device functionality. Our testing not only meets compliance but ensures devices are secure enough to protect patients’ lives.

Regulatory Alignment

Every test and report aligns with FDA, EU MDR, and ISO standards, reducing the risk of deficiencies or resubmissions.

Our Penetration Testing Process Simplifies FDA Compliance

Discovery Session

We meet with your team to understand your device, its intended use, and regulatory submission requirements.

Custom Testing Plan

Our team develops a penetration testing strategy tailored to your device’s architecture, embedded systems, and network interfaces.

Rigorous Testing

We identify vulnerabilities through in-depth manual and automated testing, simulating real-world attack scenarios.

FDA-Compliant Reporting

Receive submission-ready documentation, including detailed test results, risk assessments, and mitigation recommendations.

Support Through Submission

We provide ongoing support to address any FDA questions or concerns related to our testing results.

Let’s simplify your premarket submission. Schedule your free Discovery Session today.

Trusted by Medical Device Manufacturers Worldwide

We’ve partnered with manufacturers of all sizes—from startups to global leaders—to secure FDA premarket approvals for devices like:

  • Robotic surgical systems
  • IoT-enabled diagnostic tools
  • Implantable medical devices
  • Wearable health technology
  • Complex IVD systems
  • AI-Enabled SaMD
Medical devices in the ward, resuscitation in clinic

“Blue Goat Cyber’s penetration testing gave us FDA-compliant reports and helped us secure approval on the first try. Their expertise saved us significant time and avoided costly delays.”
Director of Regulatory Affairs, Medical Device Manufacturer


“As a startup, we needed a partner who understood FDA requirements. Blue Goat Cyber delivered beyond expectations, identifying vulnerabilities and providing submission-ready reports.”
Founder & CEO, Medical Device Startup


“Unlike other firms, Blue Goat Cyber truly understands medical device cybersecurity. Their manual testing and regulatory knowledge ensured our device met compliance and protected patients.”
VP of Engineering, IoT Medical Device Company

Your Path to FDA-Approved, Secure Devices Starts Here

Don’t risk delays or deficiencies in your premarket submission. Partner with Blue Goat Cyber to ensure your devices meet FDA cybersecurity standards, protect patients, and earn trust in the marketplace.