Every device is built on open-source and third-party components, and FDA expects you to track their vulnerabilities for the life of the product. Helm imports your SBOM, runs it against the CVE database, and tells you what's exploitable, what isn't, and what to do, then keeps watching after clearance.
Generate a CycloneDX SBOM straight from C/C++ source by detecting vendored open-source libraries, parsing and embedding run entirely in your browser.
Validate format, license accuracy, and version detail, with concrete recommendations for the gaps that weaken your SBOM.
Postmarket monitoring keeps watching your SBOM as new CVEs land, so the obligation that doesn't end is one you don't have to chase.
A complete, accurate SBOM is the foundation under every postmarket obligation you have. Everything else depends on getting it right.
Customers have cut vulnerability review time dramatically by automating the match between components and CVEs, work that used to consume weeks.
Section 524B makes SBOM and vulnerability management an ongoing duty, not a one-time checkbox at submission.
Upload an existing SBOM, or build one from source with the Code Provenance Scanner. Either way, you start with an accurate inventory.
Configure and run CVE analysis, then review the exploitable findings mapped to your specific device versions.
Manage coordinated vulnerability disclosures and accept submissions from outside researchers through your public portal.
Quality validation, vulnerability analysis, and completeness recommendations, the full picture of your software supply chain in one place.
Detect vendored open-source libraries from C/C++ source via vector similarity and generate a CycloneDX SBOM, entirely client-side.
Search by product and version, with CVSS scoring, affected-version detail, and curated advisories you can trace to source.
Map CVEs to specific device versions, and run coordinated vulnerability disclosure, including a public portal for external researchers.
Vulnerability management is only as good as the intelligence behind it. Helm runs on MedISAO, curated vulnerability intelligence and a coordinated-disclosure community, paired with the same bench of former FDA reviewers who know how postmarket obligations are actually enforced.
CycloneDX SBOM · CVSS scoring · Section 524B postmarket · Coordinated disclosure · MedISAO intelligence · Lifecycle maintained
One SBOM, fully analyzed. What's in your supply chain, what's exploitable, and what to do about it.
Analyze your SBOM