Medical Device Cybersecurity: FDA 524B, IEC 81001-5-1 & SBOM
Cybersecurity is now a condition of FDA market access. Built on our FDA and IEC 60601 medical-device experience, we help you develop the security documentation, testing evidence, and postmarket processes your submission needs, aligned with QMSR / ISO 13485.
- Pass FDA Review the First Time: Section 524B security documentation and a Secure Product Development Framework that stand up to premarket scrutiny.
- Comply with IEC 81001-5-1: Secure-software-lifecycle processes for health software and health IT.
- Deliver a Complete SBOM: Software Bill of Materials generation and management for premarket and postmarket obligations.
- Build on Proven Authority: The same lab manufacturers already trust for IEC 60601 safety testing and FDA submissions.
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The team was easy to communicate with, quick to respond, and truly committed to our success. Marty, Vic , Soliman, and even the accounting team provided us with white glove service. Not to mention that their facility is truly impressive!
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The Challenge: No Cybersecurity, No Clearance
Since Section 524B of the FD&C Act took effect, the FDA can refuse to accept a premarket submission for a cyber device that lacks the required cybersecurity documentation. The updated guidance (February 2026) raises the bar further and ties cybersecurity directly into your quality system under QMSR / ISO 13485. If your device runs software, connects to a network, or could be vulnerable to threats, you must demonstrate security by design, deliver a complete SBOM, and show a credible plan to monitor and patch vulnerabilities after launch. Gaps here don’t just delay clearance—they stop it.
Our Medical Device Cybersecurity Services
An end-to-end program that takes your device from gap assessment to submission-ready documentation and postmarket readiness.
- FDA Section 524B Readiness: Gap assessment against the current FDA guidance, security risk-management documentation, and premarket submission support for 510(k), De Novo, and PMA pathways.
- Secure Product Development Framework (SPDF): Processes aligned with QMSR / ISO 13485 that demonstrate security across the total product lifecycle.
- IEC 81001-5-1 Compliance: Implementation of the health-software secure-lifecycle standard—the natural companion to IEC 60601 and Section 524B.
- SBOM Generation & Management: Machine-readable SBOMs covering commercial, open-source, and off-the-shelf components, maintained through postmarket.
- Threat Modeling & Security Testing: Structured threat modeling plus vulnerability assessment and penetration testing scoped to your device’s architecture and clinical context.
- Postmarket Vulnerability Monitoring: Coordinated disclosure processes and monitoring plans that satisfy FDA’s postmarket expectations.