Case Study: Inovytec achieves FDA 510(k) certification with Parasoft C/C++test

Inovytec Achieves FDA Certification With Customized Static Code Analysis Solution

Inovytec is a medical-device company that builds safety‑critical ventilators (the Ventway Sparrow) used worldwide during the COVID‑19 crisis. Its embedded software team faced the dual challenge of delivering clean, reliable code while meeting strict FDA 510(k) compliance for medical device software.

The team adopted Parasoft’s C/C++test and customized its static‑analysis rules to align with FDA 510(k) requirements, integrating checks into their release process. As a result, Inovytec passed 100% of the FDA 510(k) certification rules and guidelines, saw measurable code‑quality improvements, and benefits from ongoing support from Parasoft and distributor ESL.

Inovytec

Roi Birenshtok

Solution Architect and Team Leader of Embedded Software