Medical Device Software Validation Suite™ Kits
Complete FDA 510(k) compliant Validation Suite™ Kits with test procedures and Target test code ready to be built and executed on your platform.
IEC-61508 ▪ FDA510(k) ▪ IEC-60601 IEC-62304 ▪ ISO-14971
Medical Device Software Validation Suite kits includes a complete set of standards, designs, test code, trace matrices and all related documentation for FDA/CDRH certification of all classes of medical devices.
The kit includes a complete set of step-by-step instructions that guide you through the process of building, loading, running and collecting the results of the Target Integration Tests for µC/OS-II.
All other necessary documentation is included in the kit, including Unit Test procedures, plans and test results for every code module in µC/OS-II collected by VSC on a standard platform. You simply include the provided PDF files in your documentation package.
The FDA 510(k) Validation Suite Kit provides a complete set of tests and documentation to prove the suitability of the software for avionics products. The Validation Suite Kits are compatible with virtually any processor and toolset that includes an ANSI compatible C compiler.
As always, if your plans call for complete test independence, Validated Software Corporation can provide full Validation Suites run on your hardware at our test facilities. For more information click FDA 510(k) Validation Suites.
Additional information and a collection of sample certification documents are available upon request. Click on the following link to request these PDF samples in zip file format: Validation Suite™ Information Request Page.
Complete information on µC/OS-II is available on the
Micrium website.