Threat modeling, risk analysis, and gap assessment aligned with regulatory expectations for premarket and postmarket.
Learn MoreCybersecurity hardware and software design and implementation aligned with international standards and best practices.
Learn MoreThird-party penetration and vulnerability testing validating the real-world effectiveness of cybersecurity controls.
Learn MoreQ-Sub, Pre-Sub, AI, interactive review, eSTAR submission support, and general cybersecurity best-practices consulting.
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We don't hand you off between vendors. The same team performs your cybersecurity threat modeling and risk assessment, secure-by-design engineering, penetration and vulnerability testing, and eSTAR submission support — then stays on to help with FDA correspondence and your next release.

The people behind Armatyr have spent over a decade in medical systems cybersecurity — across academic research and industry practice — supporting device manufacturers, healthcare systems, and federal partners, long before founding this firm. Their combined experience includes:

Medical device cybersecurity is still a small, young field, and it grows stronger when knowledge moves freely. Our team teaches Security and Privacy in Computing and Medical Device Cybersecurity at Johns Hopkins, directs the university's Health and Medical Security Lab, and publishes and speaks at venues like DEF CON's Biohacking Village — alongside pro-bono and nonprofit work for manufacturers and researchers who couldn't otherwise access this expertise.
Built on more than a decade of practitioner experience securing medical systems since 2015, our firm partners with manufacturers on:
Tell us about your device and where you are in the development or regulatory process — we'll get back to you shortly.