LogoLogo
Get FDA readyServicesSolutionsGuardian helpGet a demo
  • Helm help center home
  • Get Started
    • Helm features
    • Quickstart process
    • Understand data sources and update frequency
    • Get familiar with the Helm UI
      • Understand your dashboard
      • Helm terminology
    • Don't have an SBOM?
      • Why SBOMs are critical to your present and future
      • Generate CycloneDX SBOM with open-source tools
      • Generate SPDX SBOM with open-source tools
        • Generate SBOM with Yocto on Linux
      • Convert your SBOM from CSV to CycloneDX
      • Get expert Services help
    • Upload your first SBOM
      • Upload or convert .zst SBOM files from Yocto on Linux
  • Automate and integrate
    • Automate and integrate risk prioritization and management
    • Automate SBOM and vulnerability management via Helm API SDK
    • Automate SBOM management via GitHub action
    • Automate SBOM management via MS Azure DevOps extension
    • Create and manage lifecycle rules to automate EOS and EOL information across all products
  • Match components
    • Match unmatched components
    • Understand match statuses
    • Understand match sources
    • Create and manage alias rules to match and rematch components across all products
  • manage sboms
    • Manage SBOM
      • Manage component
      • Manage licenses
      • Create, edit, or merge SBOMs
      • Export your SBOM
      • Upload new version of SBOM with each release
      • Archive a product or product version
    • Find out what products contain a particular component
  • manage vulnerabilities
    • Check whether a particular vulnerability impacts your products
    • Manage vulnerabilities
      • Identify and prioritize exploitable vulnerabilities
        • Get email notifications for new vulnerabilities
        • Send email with vulnerability details for future prioritization
        • Understand issue severity level
          • Understand the CVSS vulnerability scoring system
      • Rescore vulnerabilities in bulk or individually
      • Remediate vulnerabilities in bulk or individually
      • Patch Windows vulnerabilities in bulk or individually
      • Export vulnerabilities
  • Ensure FDA readiness
    • FDA-ready SBOM and vulnerability reports
      • Meet FDA requirements with your FDA SBOM report
      • VEX and VDR reports
    • Understand new FDA cybersecurity requirements for cyber devices
      • Is my device a cyber device?
      • What if I already submitted my cyber device?
    • What should my cybersecurity management plan entail?
      • What does risk management entail?
      • Verification & Validation: Build the right product/service/system in the right way
      • Why do I need a Quality Management System (QMS)?
      • Cybersecurity is everyone's responsibility
  • Terminology
    • Cybersecurity terminology
    • What is CPE?
      • How do I read a CPE string?
  • Administration
    • Manage users
    • Manage products
    • Modify your organization name
  • what's new
    • Changelog
Powered by GitBook

© Copyright MedCrypt 2024, All rights reserved.

On this page

Was this helpful?

Export as PDF
  1. Ensure FDA readiness

FDA-ready SBOM and vulnerability reports

PreviousExport vulnerabilitiesNextMeet FDA requirements with your FDA SBOM report

Last updated 5 months ago

Was this helpful?

Helm provides you with detailed FDA-ready reports, including VEX, VDR, and the only FDA expert-crafted SBOM to ensures you meet FDA SBOM submission requirements.

  • : This is the only SBOM that ensures you meet FDA requirements, specially crafted by our team of FDA experts to help ensure a successful FDA submission. You will need to have both SBOM and vulnerability access for this product version to export this report.

  • CycloneDX SBOM: Exports an enriched version of your SBOM in CycloneDX JSON format, including any CPE/PURL matching data that was identified through automatic or manual matching, or that you specified manually, as well as vulnerabilities and license data. You will need to have SBOM access for this product version to export this report, and also vulnerability access to export it with vulnerabilities. Note that although you can import in CycloneDX 1.3, 1.4, or 1.5, Helm currently exports in only CycloneDX 1.4 — if we need to prioritize other support.

  • SPDX SBOM: Exports an enriched version of your SBOM in SPDX format, including any CPE/PURL matching data that was identified through automatic or manual matching, or that you specified manually, as well as vulnerabilities and license data. You will need to have SBOM access for this product version to export this report, and also vulnerability access to export it with vulnerabilities.

  • SBOM CSV: Exports an enriched version of your SBOM, including any CPE/PURL matching data (that was identified through automatic or manual matching, or that you specified manually), as well as license and lifecycle data. You will need to have SBOM access for this product version to export this report.

  • : Export your Vulnerability Disclosure Report (VDR), containing all SBOM and vulnerability data, including analysis and remediation plans for all of your product's vulnerabilities. Offering comprehensive insights into identified vulnerabilities, these reports equip you with proactive mitigation strategies, bolstering your defense against emerging threats. You will need to have both SBOM and vulnerability access for this product version to export this report.

  • : Export your Vulnerability Exploitability eXchange (VEX) report to easily and confidently report on exploitability and potential impact for all vulnerabilities that have a VEX status. You will need to have both SBOM and vulnerability access for this product version to export this report.

  • Vulnerabilities CSV: Export all of your vulnerabilities in CSV format. You will need to have vulnerability access for this product version to export this report.

Make sure that you have a product and version selected, which will enable you to access the reports, providing that you have the appropriate permissions for them. If you still see these report "cards" and buttons grayed out (disabled), that means that you do not have permissions to export that report. Hover over the disabled button to see what , then contact your administrator.

Helm provides you with detailed FDA-ready reports, including VEX, VDR, and the only FDA expert-crafted SBOM to ensures you meet FDA SBOM submission requirements.

Why are some reports disabled?

Make sure that you have a product and version selected, which will enable you to access the reports, providing that you have the appropriate permissions for them. If you still see these report "cards" and buttons grayed out (disabled), that means that you do not have permissions to export that report. Hover over the disabled button to see what , then contact your administrator.

Will existing SBOM component hash information be exported?

If your SBOM contained any component hashes when uploaded, that information was retained and will be exported intact to any SBOM report.

Medcrypt FDA SBOM
let us know
CycloneDX VDR
CycloneDX VEX
user role
user role