FDA 510(k)Certification Rules & Guidelines
Inovytec is an innovative medical device company that develops cutting-edge solutions for respiratory and cardiac failures. During the COVID-19 crisis, Inovytec has been a vital supplier of ventilators around the world, delivering critical care to patients suffering respiratory symptoms from the contagious disease.
The embedded development team at Inovytec delivers medical devices with safety-critical software like the Ventway Sparrow, which is a groundbreaking family of transport and emergency ventilators designed to stand up to the harshest of conditions while providing reliable high-performance ventilation at all times.
On a mission to deliver clean code and be compliant with the FDA 510(k) regulation inspection, Inovytec started using Parasoft’s static analysis for C and C++ solution.
To satisfy the FDA 510(k) certification, the embedded software development team customized a set of rules in Parasoft C/C++test to the standard.
“Every time we are going to release a new software version of the Ventway Sparrow ventilator, we make sure that the static analysis from Parasoft is configured to run according to the FDA regulation definitions. We not only noticed improvements in code quality, but C/C++test has really helped us in our static analysis verification activities and goal of achieving FDA 510(k) certification.”
— Roi Birenshtok, solution architect and team leader of embedded software at Inovytec
With customized C/C++ static code analysis rules, Inovytec was able to pass 100% of the FDA 510k certification rules and guidelines.
Parasoft is the testing solution of choice at Inovytec. With ESL as a distributor of Parasoft products in Israel, Birenshtok says that anytime they need help or have questions, they just call the company’s managing partner, Dani Liezrowice, who takes action immediately. Inovytec appreciates the support from ESL and Parasoft.