ThreadX Medical Validation Suites for
FDA/CDRH 510(k), IEC 62304 Certification 



Like most other segments, creating medical software is consuming greater amounts of time, resources, and budgets than ever before. When coupled with a trend that seems to be standard for all segments – “more features, shorter market windows, shrinking development teams and budgets that don’t seem to grow quite as quickly as the project scope does” getting to market on time and on budget has development teams scrambling to keep up. If you are a ThreadX user, VSC can help you save time, save money and to reduce project risk.  

Validation Suites for ExpressLogic ThreadX are for developers who use ThreadX but do not want to incur the overhead associated with rendering ThreadX certified in their device. Validation Suites demonstrate that the processes, activities, and tasks defined by IEC 62304 were faithfully followed satisfying the requirements and objectives of IEC 62304 for the applicable device class. Validation Suites are a semi-bespoke product that supports all APIs, Services, and legal configurations of both the Core ThreadX software and the ThreadX hardware abstraction layer that binds the RTOS software to the specific processor used in your project.

Our philosophy is to compliment your business, not constrain it. That applies from everything from our license to providing support and service after the sale. Ordering a Validation Suite is easy. You specify:

  • Processor
  • Development board
  • Compiler
  • Class


We do the rest!

Typically delivered in 60 days or less, your Validaiton Suite will contain the development artifacts and test results based on your specifications listed above.

Complete, modular, and self-contained Validation Suite is a drop in component that is easy to integrated and is compatible with any development and test program. Our turnkey Validation Suites have an affordable COTS price point yet offer the convenient, flexible utility one sees in custom products costing much more. The scope of a Validation Suite may be extended to include additional low-level processor, board related software and drivers. Check with VSC to see how we might help on this or your next project.

Additional information is available via the 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 .

Medical Validation Suite Contents

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

Software Safety Requirements Specification
Software Safety Validation Plan
Software Configuration Management Plan
Software Development Plan
Software Quality Assurance Plan
Software Verification Plan
Product Source Code w/conditional test code
Software Requirements Document
Software Design Document
Integration Test Plans and Code
Integration Test Source
Unit Test Plans and Code
Unit Test scripts
Assembly Language Coding Standard
C Language Coding Standard
Software Design Standard
Software Requirements Standard
Code Review Procedure
Document Review Procedure
Document Review Sheets
Code Review Sheets
Requisite Pro database and reports
Target Software Safety Validation Plan
Target Software Requirements Document
Target Software Design Document
Target Source Code w/conditional test code
Target Integration Test Source
Integration Test Plans and Code
Integration Test Procedures
Integration Test Report
Integration Test Project Files
Target Software Unit Test Plans
Target Unit Test scripts
Unit Test Tool Libraries ported to target
Unit Test Project Files
Target Unit Test Procedures
Target Unit Test Reports
Safety Manual
Software Correlation Matrix/Test Coverage Report
Software Life Cycle Environment Configuration Index/Software Configuration Index
Software Accomplishment Summary
Document Review Sheets
Code Review Sheets
Process Review Checklists and Audit Reports
Requisite Pro database and reports
Lint Test, Unit Test & Integration Test Results
Lint static analysis configuration files
Compiler Tool Qualification Plan**
Cantata Tool Qualification Plan**
**Class III or on request. 

     

 

Medical Links

Medical Certification Solutions Overview

Medical Validation Suites
Medical Suites for ExpressLogic

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