Finite State is the Product Security Automation Platform for medical devices, uniting firmware, binaries, and source code into a single, ground-truth system of record. Automated workflows prioritize reachable risk and continuously produce submission-ready evidence that stays current across the device lifecycle.
Medical device teams are now required to prove cybersecurity at submission and maintain it postmarket — not just run point-in-time scans.
Costly Recalls and Field Safety Risk
Late-breaking vulnerabilities and supplier changes force shipment holds, urgent patches, or recalls when teams can’t quickly determine which builds and products are impacted.
Premarket Submission Pressure (FDA 524B)
SBOMs, risk documentation, and cybersecurity evidence are rebuilt per submission, creating delays and inconsistent artifacts across reviews and versions.
Vulnerability Noise and Triage Gridlock
High-volume scanner findings lack device context, slowing remediation and leading to inconsistent “affected / not affected” decisions across releases.
Postmarket PSIRT Pressure
New CVEs and exploit activity require fast answers. Without build-level ground truth, impact analysis and customer communications become slow and high-risk.
Finite State helps teams keep security decisions and supporting evidence current across builds, variants, suppliers, and long device lifecycles.
Ground-Truth Inventory + Impact Analysis
Unify firmware, binaries, source, and supplier SBOMs into a versioned system of record so “new CVE to impacted builds” is fast and defensible.
Submission-Ready Evidence Maintained Continuously
Maintain SBOM/VEX, traceability, and verification evidence as the product evolves, so exports are ready without rebuilding packages per submission.
Exposure-Driven Prioritization and VEX Workflows
Prioritize what’s reachable and relevant, and produce defensible VEX decisions with rationale that stays consistent across reruns.
Continuous Monitoring and Customer-Ready Outputs
Track exposure as new intelligence emerges and export SBOMs, VEX, and evidence packs for internal teams, customers, and auditors.
What medical device teams gain once compliance becomes repeatable.
Submission evidence that’s faster to prepare and easier to defend. Maintain firmware-grounded SBOMs, security decisions, and supporting evidence as the product evolves, so premarket artifacts are ready without rebuilding them from scratch.
Defensible prioritization that keeps teams focused on real risk. Use reachability and device context to prioritize what’s relevant in the shipped device and produce consistent “affected/not affected” decisions with defensible rationale, including VEX outputs.
Clear ownership and traceability across supplier software inputs. Consolidate supplier SBOMs and evidence into a single system of record, standardize artifact exchange, and keep supplier changes visible across versions—so accountability is operational, not ad hoc.
Faster answers when new vulnerabilities emerge in the field. Use living SBOMs and version/variant tracking to quickly determine which products are impacted, drive remediation workflows, and export customer- and audit-ready outputs with a full audit trail.
How FDA 524B, IEC 62304, EU MDR, and UL 2900 translate into concrete security and compliance requirements—and how Finite State helps teams maintain the required evidence.
Medical device manufacturers rely on Finite State to protect patients and achieve regulatory compliance.
See how Finite State supports medical device security and compliance with evidence grounded in shipped software.
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