| Achieve
FDA compliance with fewer resources
The FDA, in its “General Principles of Software
Validation”, requires manufacturers to Implement
a complete Defect Prevention Strategy, including extensive
testing and validation after every change.
As a leading static verification technique, we provide
exactly the type of extensive analysis required by the
FDA, while demanding far less time and effort than conventional
white-box testing and code inspection. While it may
take a day to review a file and about a week to achieve
100% coverage using other test cases and code review,
our analysis is entirely automatic, and going through
its results can be completed in minutes.
Long and rich experience in Medical
Devices
Our solution has been specifically developed with the
needs of critical industries in mind. It addresses the
needs of organizations that must show compliance with
the world’s most stringent standards, such as
FDA in Medical, DO-178B in Aerospace, MISRA in Automotive,
etc. We are helping prestigious manufacturers like Tyco-Mallinckrodt
and Siemen's meet the requirement of regulatory instances
while reducing testing time, minimizing code inspection
costs and achieving an unparalleled level of defect
prevention.
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