Secure. Compliant.

Submission-Ready.

Cybersecurity testing, risk analysis, and FDA-ready documentation for medical devices.

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Aegis Med Lab provides specialized cybersecurity testing and regulatory documentation support for medical device manufacturers. Based in Orange County, CA, we partner directly with engineering and quality teams to deliver secure, submission-ready products.

  • Several printed reports and documents related to FDA cybersecurity assessment spread out on a gray desk, a black pen resting on one of them, a pair of glasses, a black coffee mug, and a computer keyboard in the background.

    Complete cybersecurity submission packages.

  • A man working at a desk in a high-rise office with multiple computer monitors displaying data and graphs, with large windows showing a cityscape outside.

    Engineering-focused fixes to close findings quickly.

  • Medical monitor displaying heart rate data connected to a medical device on a white table in a healthcare setting.

    Hands-on device, firmware, and network testing.

Who We Are?

We are a U.S.-based cybersecurity company with many years of experience securing safety-critical embedded systems for medical devices. Our team combines deep knowledge of real-time firmware, medical device software, and FDA regulatory expectations.

We are not a general IT security firm. We work only with medical devices and only with embedded systems.

Our mission is simple:

Help medical device manufacturers meet FDA cybersecurity expectations without delays, surprises, or regulatory risk.

What makes us different?

Most cybersecurity firms test web apps, cloud systems, or corporate IT networks.
Medical devices are different.

We specialize in:

  • Embedded firmware and real-time operating systems

  • Communication protocols (USB, Ethernet, Wi-Fi, Bluetooth, serial)

  • Sensors, actuators, and safety-critical control loops

  • Medical device software lifecycle (IEC 62304)

  • Risk management (ISO 14971) - Risk analysis from the clinical perspective.

  • Our work aligns with recognized medical device software and cybersecurity standards, including IEC 62304, ISO 14971, IEC 81001-5-1, AAMI TIR57, and applicable FDA premarket and postmarket cybersecurity guidance, ensuring a rigorous and regulator-ready approach for embedded medical systems.

We speak engineering, clinical and regulatory — so your cybersecurity work is not just technically strong, but also defensible in front of FDA

Our Team

Aegis Medical Laboratory - California

 Powered by a U.S.-based team with over 20 years of experience in medical device software and embedded systems, the company is singularly focused on cybersecurity for connected medical technologies where patient safety and reliability are critical.

Our experts apply a clinical risk–driven approach, aligning cybersecurity analysis with real-world device use, recognized standards, and FDA requirements. The result is clear, defensible, FDA-ready documentation that supports regulatory submissions, audits, and long-term compliance with confidence.

 

Group photo of eleven people, four women and seven men, in an office with a dark blue wall. The wall displays the logo and name "Aegis Med Law California." Some individuals wear casual clothing, while others are dressed in black polo shirts with a logo. Everyone is smiling and sitting or standing in two rows.