510(k)Ophthalmology
Multi-Platform AI Medical Software (Desktop + Mobile + Cloud)
?Before ESL
- • 3 platforms (C++ desktop, C# server, Java mobile) - no unified evidence
- • No consistent coding standard enforcement across platforms
- • Coverage measured differently on each platform - not comparable
- • No traceability across the multi-platform architecture
VAfter ESL
- • SBOMator™ produced SBOMs for all 3 platforms from source, packages, and containers
- • Parasoft C/C++test for C++, Parasoft dotTEST for C#, Parasoft Jtest for Java
- • Unified coverage methodology: branch coverage for all Class B components
- • Cross-platform traceability matrix in Polarion ALM connecting all platforms
Result: 510(k) cleared. ESL’s technology-independent execution was key - one team, one evidence standard, three platforms.
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 →