Postmarket Medical Device Cybersecurity

FDA clearance isn't the finish line - it's the start of your postmarket cybersecurity obligations. This hub collects our postmarket service, CVD program guidance, legacy device strategy, and the standards (AAMI TIR97, IEC 81001-5-1) that define what 'good' looks like.

Services

• FDA Postmarket Cybersecurity

  Once cleared, your device still needs eyes on it. We handle SBOM monitoring, coordinated vulnerability disclosure, patching, and FDA-aligned reporting.

• Legacy Device Protection

  Compensating controls, network isolation, and monitoring for fielded devices that can't be easily updated - keeping clinical operations running.

• FDA-Compliant SBOM Services

  Machine- and human-readable SBOMs with NTIA minimum elements, vulnerability mapping, and end-of-support tracking - built for FDA review.

In-depth guides

• Postmarket Cybersecurity Readiness PlanFree Guide · Updated 2026 · FDA-Aligned The Postmarket Cybersecurity Readiness Plan Premarket → Launch → Operate What FDA expects, and when. A three-phase plan for the cybersecurity work that starts before your 510(k) is filed, lights up before your first device ships, and runs for the life of the p

Standards & guidance

Defined entries from our MedTech Cybersecurity Standards Glossary.

• AAMI TIR97Postmarket Security Risk ManagementPostmarket companion to TIR57/SW96 - CVE monitoring, vulnerability triage, patching, and coordinated disclosure.
• IEC 81001-5-1Health Software Security ActivitiesThe international standard the FDA points to for the Secure Product Development Framework (SPDF). Defines security activities at each lifecycle stage - planning, requirements, design, implementation, V&V, release, and post-market.
• Section 524BFD&C Act Cyber Device RequirementsAdded by the Consolidated Appropriations Act, 2023, Section 524B gives the FDA explicit authority to require a complete cybersecurity package in every premarket submission for a cyber device, and to refuse submissions that lack one.
• FDA 2026 GuidanceFDA Premarket Cybersecurity Guidance (Feb 3, 2026)The FDA's final premarket cybersecurity guidance, effective February 3, 2026. Defines the seven-section cybersecurity submission format reviewers now enforce at Technical Screening, replacing the 2023 draft. Operationalizes Section 524B of the FD&C Act.

From the blog

• Conducting a Medical Device Security AuditThis post outlines the key steps to perform a comprehensive cybersecurity risk assessment and testing of medical devices.
• Best Practices for Medical Device CybersecurityMedical device cybersecurity best practices for 2025: threat modeling, SBOM, penetration testing, secure updates, and FDA 524B/SPDF readiness.

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