SBOMs for Medical Devices

Services

• Medical Device SBOM Services

  Medical device SBOM services with source, build, and binary evidence reconciliation, component vulnerability assessment, and support-status verification. SPDX by default; fixed fee after scoping.

• FDA Postmarket Cybersecurity

  Once cleared, your device still needs eyes on it. We handle SBOM monitoring, coordinated vulnerability disclosure, patching, and FDA-aligned reporting - delivered as one-off projects or as an annual TPLC Partnership covering an entire product line.

• Legacy Device Protection

  Compensating controls, network isolation, and monitoring for fielded devices that can't be easily updated - keeping clinical operations running without touching the cleared design.

In-depth guides

• The MedTech Cybersecurity Standards DecoderA plain-English field guide to Section 524B, IEC 81001-5-1, ANSI/AAMI SW96, ISO 14971, and more: what each requires and how they connect in eSTAR.
• Postmarket Cybersecurity Readiness PlanA three-phase plan, Premarket → Launch → Operate, 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 product. Aligned to the FDA February 2026 final guidance.
• CPE vs PURL for Medical Device SBOMs: Which Identifier and WhenHow CPE and PURL identifiers differ, why medical device SBOMs need both, and how to map PURL to CPE for FDA postmarket CVE monitoring under Section 524B.
• SBOM for Medical Devices: The 2026 FDA Pillar GuideWhat an SBOM is, why the FDA requires one under Section 524B, SPDX vs CycloneDX, how to generate and submit one, and how it powers postmarket vulnerability management.
• SBOM in a 510(k) Submission: Where It Goes (2026)Where the SBOM belongs in a 510(k) eSTAR submission, what has to accompany it, how it ties to the vulnerability assessment, and the placement errors that trigger deficiencies.
• CycloneDX vs SPDX: Medical Device SBOM Compliance GuideDoes the FDA prefer CycloneDX or SPDX? Compare SBOM formats for medical device cybersecurity compliance and premarket 510(k) submissions.
• Who Is Responsible for Supplier SBOMs? (2026)Supplier SBOM responsibility under FDA Section 524B: the manufacturer owns the device SBOM, what to require in supplier contracts, and how to document gaps reviewers will accept.
• Postmarket SBOM Maintenance for Medical DevicesHow to maintain SBOMs across a fleet of cleared devices: regeneration cadence, vulnerability triage, VEX, and the postmarket plan that ties it together.
• AIBOM for Medical Devices: AI Bill of Materials (2026)What an AIBOM is, how it differs from an SBOM, recommended inventory fields for AI-enabled devices, and how to generate one in CycloneDX or SPDX.

Standards & guidance

Defined entries from our MedTech Cybersecurity Standards Glossary.

• FDA 2026 GuidanceFDA Premarket Cybersecurity Guidance (Feb 3, 2026)The FDA's final premarket cybersecurity guidance, issued February 3, 2026. Provides nonbinding recommendations for cybersecurity documentation and explains Section 524B obligations. It directly supersedes the June 27, 2025 guidance; September 2023 was a final guidance, not a draft.
• Section 524BFD&C Act Cyber Device RequirementsSection 524B of the FD&C Act (the statutory partner to 21 CFR 807.81) was added by the Consolidated Appropriations Act, 2023. It 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. It works alongside 21 CFR 807.81, which sets the 90-day 510(k) filing floor.
• 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.
• AAMI TIR97Postmarket Security Risk ManagementPostmarket companion to TIR57/SW96 - CVE monitoring, vulnerability triage, patching, and coordinated disclosure.

From the blog

• Medical Device Cybersecurity: 2026 Best Practices GuideA practitioner build plan for medical device cybersecurity: what FDA reviewers ask for, what evidence satisfies SW96, SBOM, and testing, and what it costs.

Related FDA deficiencies

The deficiency letters reviewers most often write on submissions in this topic area. Each links to the full response playbook.

• Non-Conformant SBOM

  Your SBOM is missing required minimum elements, transitive dependencies, or is delivered in an unsupported format.

  Response playbook
• Missing CVE / CWE Mapping

  Reviewers cannot find the CVE-to-component or CWE-to-weakness mapping that lets them verify your vulnerability posture.

  Response playbook
• Inadequate Vulnerability Management Plan

  Your VM plan lacks defined triage timelines, a coordinated vulnerability disclosure path, or a documented patch-deploy mechanism.

  Response playbook
• Inadequate Post-Market Cybersecurity Plan

  Your post-market plan lacks monitoring, patching commitments, customer communications, or end-of-support handling.

  Response playbook

Related topics

Adjacent hubs in the same regulatory lifecycle, with the guides, articles, tools, and questions they cover that this hub does not.

• Postmarket Medical Device CybersecurityShares FDA 2026 Guidance, Section 524B, IEC 81001-5-1 · Same service track: Medical Device SBOM Services

  Postmarket cybersecurity obligations begin the day a cyber device is cleared or approved.

  • AAMI TIR57 vs TIR97: Medical Device Risk Management GuideGuideCompare AAMI TIR57 vs TIR97. Learn how these cybersecurity risk management standards differ and how to apply them for FDA premarket and postmarket compliance.
  • Conducting a Medical Device Security AuditArticleStep-by-step guide for medical device manufacturers to run a cybersecurity audit: scope, threat modeling, SBOM review, testing, and FDA-aligned documentation.
  • HHS HPH CPGs for Medical Device ManufacturersGuideHow the HHS HPH Cybersecurity Performance Goals map to manufacturer obligations, MDS2 disclosures, and Section 524B evidence.

  What does Section 524B require for postmarket?

  Section 524B requires a plan to monitor, identify, and address postmarket cybersecurity vulnerabilities and exploits in a reasonable time, plus processes to make updates and patches available on a defined cadence. In practice that means continuous SBOM monitoring with VEX triage, a published coordinated vulnerability disclosure program, a documented patch pipeline with validation evidence, and a defined process for FDA reportable event communications. The FDA's postmarket cybersecurity guidance expands on each of these expectations with concrete examples of the artifacts reviewers expect during inspections and supplements.

  More Postmarket Medical Device Cybersecurity FAQs
• MedTech Cybersecurity StandardsShares FDA 2026 Guidance, Section 524B, IEC 81001-5-1 · Same service track: Medical Device SBOM Services

  The standards MedTech teams actually need are a short list: ISO 14971 for safety risk management, ANSI/AAMI SW96:2023 for security risk management, AAMI TIR57 as its predecessor and companion, IEC 62304 for software lifecycle, IEC 81001-5-1 for secure development, and UL 2900 series where a certification is contractually required.

  • ISO 14971 vs AAMI TIR57: Hazard Analysis Meets Cybersecurity RiskGuideHow safety hazard analysis and security risk analysis run in parallel and converge at the patient-harm column, with a side-by-side mapping table.
  • IEC 81001-5-1 Explained: Health Software Security RequirementsArticleIEC 81001-5-1 explained: the health software security activities it requires, how it builds on IEC 62304, and how it supports an FDA SPDF.
  • IEC 81001-5-1 Security Lifecycle Evidence TableGuidePractical IEC 81001-5-1 evidence mapping: lifecycle activities, artifact owners, review questions, and a worked traceability example for health software.

  Which standards does the FDA actually require?

  The FDA requires compliance with statute (Section 524B) and 21 CFR Part 820 / QMSR. They recognize - but don't strictly mandate - consensus standards like AAMI SW96, IEC 81001-5-1, and ISO 14971. In practice, declaring conformance to those standards is the cleanest path through review.

  More MedTech Cybersecurity Standards FAQs
• Software as a Medical Device (SaMD) CybersecurityShares FDA 2026 Guidance, Section 524B, IEC 81001-5-1 · Same service track: Medical Device SBOM Services

  Software as a Medical Device is a cyber device whenever it has software and the ability to connect to the internet, which is nearly always.

  • ISO/TR 80002-2 and Validating Cybersecurity Tools (2026)GuideISO/TR 80002-2:2017 governs validation of non-device software used in the quality system. How it applies to SBOM generators, SCA scanners, threat modeling tools, and signing pipelines.
  • SaMD vs SiMD: What Manufacturers Need to KnowArticleLearn the difference between SaMD and SiMD, why it matters for FDA strategy, and how to build secure-by-design medical devices across your product.
  • SaMD Cybersecurity FDA Requirements: 2024 Compliance GuideGuideMaster SaMD cybersecurity FDA requirements. Learn premarket submission needs, SBOM standards, and postmarket monitoring for SaMD under Section 524B.

  Is my cloud-only software a medical device?

  If it meets the FDA's definition of a 'device' under FD&C Act Section 201(h) and is intended for diagnosis, treatment, prevention, or mitigation of disease, it's SaMD - regardless of whether it ever runs on a hardware device. The IMDRF SaMD framework is the international reference; the FDA's Digital Health Center of Excellence publishes US-specific guidance. If you're unsure, the right move is a regulatory-strategy consult before you've shipped, not after.

  More Software as a Medical Device (SaMD) Cybersecurity FAQs