Medical Validation Kits for
Micrium µC/OS-II and µC/OS-III C
ertification

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


Medical device software Validation Kits include a complete set of standards, designs, test code, trace matrices and all related documentation for FDA/CDRH certification of all classes of medical devices.

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 is available upon request. Click: Information Request Page.

Need a custom I/O driver?

VSC offers a wide range of customizable Portable Driver packages with full certification artifacts. 
Click here for more info .

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. Also, check out our Side by Side Comparison of Suites vs. Kits.

Medical Validation Kit Contents

Documents listed below are a representative sample. Actual documents, names, and their content is subject to change.

Software Safety Requirements
Software Safety Validation Plan
Software Development Plan
Software Configuration Management Plan
Software Quality Assurance Plan
Software Verification/Test Plan
Software Coding Standards
Software Requirements Standards
Software Design Standards
Requirements Specification
Design Description
Unit Test Procedures, Plans and Reports
Target Integration Test Procedure, Plan, and Code
Test Report Template
Trace Matrices
Configuration Index
Safety Manual
Complete step-by-step instructions

 

 

     

 

Medical Links

Medical Certification Solutions Overview

Medical Validation Suites
Medical Suites for Micrium

Medical Validation Kits
Medical Kits for Micrium  

For any Medical Software
Medical Validation Templates

Medical FAQ

Medical Resources

Need more information?

Use our: Information Request Form

E-mail: info@ValidatedSoftware.com

Phone: 1-760-448-5391