Medical Validation Products Overview

FDA 510(k) ▪ IEC 62304

Proven, Cost-effective, and Flexible

VSC has an extensive background in delivering certification artifacts for all assurance levels of medical devices. Our Validation Products have been used for all classes of medical device certification and meet or exceed the regulatory requirements of IEC 62304. Our Medical Validation Suites and Medical Validation Kits are the fastest, easiest and, by far, the most affordable approach to device certification.

APIs Identical to Commercial Versions

Unlike some companies, every VSC product has the same API as the manufacturer's commercial product. This ensures that all functions are identical to the version you used to develop your application.

For developers not using one of our supported RTOSes or needing to create an IEC 62304 compliant development and test program, our Medical Validation Templates are available to jump start that effort.


VSC's Four Validation Product Tiers

Suites

Complete
Ready to Submit
for Certification
Validation Suites™ are a turnkey delivery of certification artifacts specifically developed and tested to meet the exact needs of your project. You specify the processor, the compiler, and the Safety Integrity Level. We do the rest. In 60 days or less you receive a hardware tested, ready to reference set of
IEC 62304 artifacts for the RTOS embedded in your device. Our best value, the Medical Validation Suite is the fastest, easiest and most cost-effective way to achieve certification of the RTOS in your device.
   
Kits

DIY Port, then
Ready to Submit
for Certification
Validation Kits™ are what we use as the starting point for every Medical Validation Suite. Validation Kits are for those who have the time, resources or need to create their Validation Suite at their own facility. Approximately 90% complete, the Validation Kit comes with a detailed manual, samples, examples and the templates you need to customize the kit to your specific hardware.
   
Templates

DIY with
your software
and our Templates
Validation Templates™ are for those new to the certification process looking to implement a proven, practical, affordable approach to device certification – and get it right the first time! Unlike our other Medical products, our Validation Templates are not tied to any other software implementation. They provide the foundation for a development and test program.
   
Custom

Documentation
and testing
for your Software
Validated Software can provide custom documentation and testing for any software. Whether you are starting a new project or moving a legacy package into a product that needs to meet safety-critical standards, we can provide everything required, including advice on setting up a compliant development and test process.

Our Guarantee

Our products undergo continuous evaluation and improvement. Every release builds on the lessons learned previously so that the products are easier to use, more accessible and continue to press the envelope of cost-effectiveness.  In addition to an unbroken record of successful certifications, you have our guarantee that we will fix any issues found in our products that jeopardize your device certification.

Need a custom driver?

VSC offers optional individual Customizable Portable Driver Packages with full certification artifacts.

Suites vs. Kits?

Check out our Side by Side Comparison of Suites vs. Kits.

Questions?

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


     

 

Medical Quick Links

Validation Suites
Micrium µC/OS RTOS
ExpressLogic ThreadX

Validation Kits
Micrium µC/OS RTOS

Validation Templates
Templates Pack

Time and Space Partitioned RTOS
Valid-653 / Rapid-653

Need more information?

Use our: Information Request Form

E-mail: info@ValidatedSoftware.com

Phone: 1-303-641-6672
 

FAQ