Medical Certification Solutions Overview

FDA/CDRH 510(k), IEC 62304        




VSC understands the challenges faced by developers. Our IEC 62304 artifacts have been used for all classes of device certification and meet or exceed the regulatory requirements for the US, European Union and most emerging markets. Check out your options below. You can verify for yourself that VSC has the fastest, easiest and by far the most affordable means to certify your device.

We offer three tiers of products to help with your certification.

Suites


Price: dollarsdollarsdollars
Convenience: check mark
Value: value

Complete, Ready
to Submit for Certification

Validation Suite™, is the easiest way get the OK and give yourself more time to play. Aside from taking on a more proactive approach to supporting the processors used in the medical market, it is not only the easiest, fastest way to get IEC 62304 compliant artifacts.
Medical Suites
for Micrium
Medical Suites
for ExpressLogic
  
 

   

Kits

Price:
Convenience:
Value:

DIY Port then
ready to Submit
for Certification

Validation Kits™  are what we use as the starting point for every Medical Validation Suite. Validation (Suite) Kits are a fallback position for those using processors or tools that are not yet supported by Valid-62304. Medical Validation Kits represent an extraordinary value. The approximately 90% complete Validation Kit comes with a detailed manual, samples, examples and the templates you need to customize the kit to your specific hardware.
Medical Kits
 for Micrium
 

   

Templates

Price:
Convenience:
Value:

DIY using your RTOS and our Documentation  Templates.

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

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 I/O driver?

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

Suites vs. Kits?

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

Questions?

Check out our FAQ page and the Resources page.
Or use our
Information Request Form

 

 

 

 

 

 

 

     

 

Medical Links

Medical Certification Solutions Overview

Medical Validation Suites
Medical Suites for Micrium
Medical Suites for ExpressLogic

Medical Validation Kits
Medical Kits for Micrium  

For any Medical Software
Medical Validation Templates

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

Medical FAQ

Medical Resources

Need more information?

Use our: Information Request Form

E-mail: info@ValidatedSoftware.com

Phone: 1-760-448-5391