Medical Validation Products Overview
IEC 62304 ▪ FDA 510(k)
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 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 Validation Product Tiers
| Suites Complete Ready to Submit for Certification |
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| 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.
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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.
Questions?
Please go to our FAQ page or use our Information Request Form.
