Inovytec Ventway Sparrow - FDA 510(k) with Parasoft C/C++test
?Before ESL
- • Embedded ventilator software needed FDA 510(k) compliance with no static analysis baseline
- • No customized rule set mapped to FDA 510(k) certification requirements
- • Code quality issues hidden across the embedded C/C++ codebase
- • No automated verification workflow before software releases
VAfter ESL
- • ESL deployed Parasoft C/C++test with FDA 510(k)-customized static analysis rules
- • Every Ventway Sparrow release now runs Parasoft static analysis configured to FDA regulation definitions
- • 100% of FDA 510(k) certification rules and guidelines passed
- • Direct support from ESL (Dani Liezrowice) as Parasoft’s Israeli distributor - immediate response on any issue
- • Code quality improvements achieved alongside full compliance verification
Result: FDA 510(k) certification achieved. Parasoft C/C++test became the testing solution of choice at Inovytec, with ESL providing ongoing local support as Parasoft’s authorized Israeli distributor.
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 →