FOR REGULATORY AFFAIRS + ENGINEERING LEADERSHIP
Submission-ready SBOMs. Audit-ready evidence. For every device release.
FDA section 524B premarket cybersecurity requires SBOMs and ongoing vulnerability monitoring. Auditors ask for evidence years after ship. Build records scattered across CI systems do not survive that question.
HOW TEAMS USE REARM FOR THIS
01
Submission-ready SBOMs
Generated and stored per device release, versioned and tied to the release that produced them.
↳ SBOM/xBOM Management02
Postmarket monitoring
New CVEs and KEV entries evaluated against shipped versions, not just the latest build.
↳ Findings Aggregation03
Documented, enforced release criteria
Release policies encode your criteria once; every release is checked automatically, with evidence.
↳ Release Policies04
Immutable release history
A record of what actually shipped, holding up years later when auditors ask.
↳ Audit Evidence STANDARDS
FDA 524BEU MDR
SBOM · VDR · KEV MONITORING · RELEASE CRITERIA · IMMUTABLE HISTORY