Secure FDA Approval with
Automated SBOM Reporting
Create comprehensive SBOMs (software bill of materials) in minutes, not weeks – ensuring your medical devices meet FDA requirements for Premarket Approval and 510(k) submissions.
Trusted by over 40,000 development teams at world-class organizations
Go to Market With Confidence
Ensure approval of your PMA and 510(k) submissions with an FDA-ready SBOM that includes all required information around components, vulnerabilities, and level of support.
Simplify Device-Level Reporting
Track all open source components within each device, manage changes across software versions, and maintain visibility into risks from your third-party software suppliers.
Automate Continuous Compliance
Continuous monitoring automatically notifies you of emerging risks to your medical devices, ensuring future compliance.
Features
Comprehensive Inventory
Maintain a central inventory of all software components in each medical device
Automated Annotations
Automatically document vulnerability details in your SBOM reports
Simplified Distribution
Share your SBOMs securely, with time-based access controls and a custom distribution portal
"(FOSSA's) SBOM support was among the most mature of vendors in this Forrester Wave."
"It was easy to integrate FOSSA into our CI pipeline to generate SBOMs."
"Reporting is one of the core functionalities that we've used from FOSSA. We issue reports, and we trust them."
Resources
Complying with the FDA's SBOM Requirements
A Framework for Evaluating SBOM Tools
Understanding and Using the CycloneDX Standard