PMAAnesthesiology
Embedded Firmware AI Medical Device (Binary-Only)
?Before ESL
- • Firmware available only as compiled binary - no full source tree
- • No component inventory for the supply chain
- • No coverage data from cross-compiled target
- • No ALM traceability - requirements in spreadsheets
VAfter ESL
- • SBOMator™ extracted SBOM from firmware binary - no source required
- • 14 CVEs correlated; 3 critical vulnerabilities patched in upstream components
- • On-target testing: module-by-module instrumentation, results merged
- • Requirements, risks, tests, and results linked in Polarion ALM
- • MC/DC coverage evidence assembled for Class C software
Result: PMA submission included complete software evidence package. SBOMator’s binary-only capability was critical - no other tool could produce the SBOM from firmware alone.
Bring ESL the software - not a cleaned-up demo
We will build, clean and connect the evidence. Start with a software evidence scoping workshop.
Schedule Scoping Workshop →