Medical Validation Suites for
Micrium µC/OS-II and µC/OS-III Device Certification

Demonstrating compliance to FDA 510(k), IEC 62304

Delivered 100% complete, Validated Software’s µC/OS-II and µC/OS-III Medical Validation Suites are ready to submit for FDA or IEC certification. Medical Validation Suites contain everything needed to demonstrate the level of confidence required for certification at any Safety Class Level. Each package contains complete designs, source code, test code, test results, trace matrices and all related documentation for certification up through Class C.

VSC’s Medical Validation Suites provide full coverage for all of the APIs and services provided by the commercial version of µC/OS. Delivered running and tested on your target hardware, each Medical Validation Suite is complete and ready for submission as delivered; for system submission, your system documentation simply references the Validation Suite as part of the delivery. Detailed instructions are provided to integrate the Validation Suite into your project.

The standard µC/OS Medical Validation Suite covers the complete RTOS and port software (hardware abstraction layer). However, VSC can extend your suite to include additional software components such as drivers and application code. Like the standard suite, your enhanced Medical Validation Suite is delivered as a single, convenient, modular, and easy to integrate package.

Our philosophy is to compliment your business, not constrain it. That applies to everything from our licensing to providing support and service after delivery.

Ordering a Validation Suite is easy.

You specify the Processor ▪ Target / Developement board ▪ Compiler ▪ Safety Class.

We do the rest!


Developed as a complete and self-contained Validation Suiteage for the RTOS components used in an embedded Medical device, VSC’s Medical Validation Suites provide full coverage for all of the APIs and services provided by RTOSes. Validation Suites contain the essential software requirements, design, source code, test code, test results, requirements trace matrix, user’s manual and all other artifacts required to certify popular embedded real-time operating system software.

Delivered running and tested on your target hardware, each Medical Validation Suite is complete and ready for submission as delivered; for system submission, the system documentation simply references the Validation Suite as part of the delivery.

Test Coverage

  • 100% Feature/Function coverage
  • 100% Statement coverage
  • 100% Decision coverage


Validated Software’s Medical Validation Suites are IEC 62304 and FDA 510(k) certifiable and have been used for devices at all levels including Class C/3.

Medical Validation Suite Contents

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

  • Plans
    Software Requirements Specification
    Software Safety Validation Plan
    Development Plan
    Configuration Management Plan
    Quality Assurance Plan
    Verification Plan

  • Standards
    Requirements Standard
    Coding Standards
    Design Standard

  • Project Documents and Code
    Requirements Document
    Design Document
    Source Code, Build Code
    Test Code and Test Projects
    Unit Test Procedures, Plans and Code
    Integration Test Procedures, Plans and Code
    Tool Qualification Plans
    Test Coverage Reports
    Trace Matrices
    Life Cycle Configuration Index
    Configuration Index
    Accomplishment Summary
    Safety Manual

  • Reviews
    Document Review Procedure
    Document Review Sheets
    Code Review Procedure
    Code Review Sheets
    SQA Checklist

 

Questions?

Please go to our FAQ page or use our Information Request Form.

 

 


     

 

Medical Quick Links

Overview
Medical Validation Products

Validation Templates
Templates Pack

Need more information?

Use our: Information Request Form

E-mail: info@ValidatedSoftware.com

Phone: 1-303-641-6672
 

FAQ