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Build secure software. Show your work.
From SBOM to regulatory documentation: Ketryx gives your team the connected context to manage and defend cybersecurity decisions across the entire development lifecycle, including AI-enabled and software-intensive devices.
Trusted by four of the world's top five medical device manufacturers.
Connecting SBOM Vulnerabilities to Safety Risk
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Most teams stitch cybersecurity compliance together from disconnected pieces: SCA scanners that flag vulnerabilities without context, threat models in spreadsheets, risk assessments that never connect back to design controls. The result is manual triage that lasts for months, documentation that's always one release behind, and security controls that quietly conflict with safety controls. The cause: no one has the full picture.
Ketryx connects your SBOM, threat model, and risk documentation into a single workflow, so your team can triage faster, trace further, and document automatically.
Cybersecurity compliance, built into how you develop
Enriched SBOM management
Turn SCA output into a documented, compliant SBOM — with component metadata (Level of support and End of life), approval workflows, and Part 11-compliant audit trails added on top.
Structured threat modeling
Bring your threat model into Ketryx as itemized, manageable threats — classified with STRIDE, scored with CVSS, and traced directly to your design controls and vulnerabilities. Your AI assistant can surface gaps you haven't considered yet
Compliance review for FDA and EU Cybersecurity Resilience Act (CRA)
Ask Ketryx AI to review your cybersecurity documentation against FDA cybersecurity guidance or EU CRA requirements. Find gaps before your auditor does.
How a Fortune 50 Robotics Company Moved 80% Faster
A Fortune 50 Robotics company partnered with Ketryx to accelerate releases and modernize risk management workflows. Improvements to its Cybersecurity System Architecture (CSA) exposed gaps in a process slowed by fragmented tools, inconsistent data, and manual handoffs. Ketryx unified these processes into an AI-driven system that streamlined prioritization and increased review throughput. The result: the team now operates 80% faster.
From SBOM to sign-off: your security workflow, connected
SBOM
Your SBOM, enriched and compliant
SCA tools give you a machine-readable component list. Ketryx transforms it into a documented, compliant SBOM, enriched with the metadata regulators require: support level, end-of-life status, security reliability ratings, and more. Bring in SPDX or CDX files or feed directly from your CI/CD pipeline. With Ketryx, the tedious manual layer disappears.
Triage vulnerabilities with full development context
A vulnerability that overrides a safety control can be life-threatening. Ketryx links cybersecurity to ISO 14971 safety risk, showing where controls reinforce or conflict — across software, AI pipelines, and deployments, with defensible traceability for FDA and EU CRA, built in.
Generate defensible, submission-ready security documentation automatically
Ketryx compiles your SBOM report, vulnerability assessment, and product security risk documentation automatically, pulling from your live project data, not a manual export. With Ketryx you can review, sign, and release. What used to take teams months now takes hours.
Ketryx supports compliance with: FDA Cybersecurity Guidance · EU Cyber Resilience Act (CRA) · IEC 62304 · ISO 14971 · ISO 13485 · IEC 62443 · IEC 81001-5-1 · QSMR
One top-five medical device company, Medtronic, reduced manual vulnerability review volume by filtering, deduplicating, and patching obsolete items automatically, reducing triage time by 80%.
90%
Reduction in SBOM documentation time
See your defensible cybersecurity posture in one place.
From SBOM ingestion to risk documentation, Ketryx connects every step of your security workflow.
Trusted by four of the world's top five medical device manufacturers.