Medical Validation Kits
Complete standards compliant Validation Kits™ with test procedures and Target test code ready to be built and executed on your platform.
FDA/CDRH 510(k), IEC 62304, IEC 60601, ISO 14971
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Kits include 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 on your target platform.
Developed as complete and self-contained support for software components used in an embedded medical device, VSC's Medical targeted Validation Kits provide coverage of all of the APIs and services supported by the Core real-time software. Sample code and test plans for Port specific tests are also included.
All necessary documentation is included in the kit, including Unit Test procedures, plans and test results for every code module in the Core product collected by VSC on a standard platform. You build and execute the provided test files on your target hardware and collect target specific results to complete the package. For system submission, your system documentation simply references the Validation Kit documents as part of the delivery.
Validation Kits are compatible with virtually any processor and toolset that includes an ANSI compatible C compiler.
Additional information and a collection of sample certification documents are available upon request. To request these PDF samples in zip file format click: Information Request Page.
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 Medical Validation Suites.