Medical Validation Suites™
FDA/CDRH 510(k) / PMA ▪ IEC-62304 / 60601 / 61508 ▪ ISO-14971
With the ever increasing price of medical software development and testing, you can now add the reliability and assurance of a thoroughly tested RTOS to your product and still reduce your development and test time and expense. For those who sell into the European Union, compliance with software standards is now a requirement to receive the CE Mark.
Delivered 100% complete, Validated Software’s Medical Validation Suites are compliant with all dominant international medical device software standards, FDA/CDRH 510(k) and PMA, ISO-14971, IEC-60601, IEC-61508 and IEC-62304. Medical Validation Suites contain everything needed to comply with international medical device software standards: designs, source code, test code, test results, trace matrices and all related documentation for classes of devices including Class III and Class C.
Developed as a complete and self-contained certification package for the RTOS components used in embedded mecical devices, VSC’s Medical Validation Suites provide full coverage for all of the APIs and services provided by the real-time 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.
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Express Logic |
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| Micrium |
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Validated Software’s Medical Validation Suites have been have been proven for certification of all classes of medical devices up to and including Class III.
Our affordable Validation Suites are available for a wide variety of RTOS and Middleware products.
Validated Software’s latest validation effort adds
Express Logic’s
ThreadX kernel to our line of Validation Suites. Like
our Validation Suites, it is proven in the safety-critical device arena.
Validation Suites are 100%
complete, support all ThreadX APIs and services, and have been used in medical devices requiring Class III rigor.
Additional information and a collection of sample certification documents are available upon request. To request these PDF samples in zip file format click: Information Request Page.
Medical Validation Suites are also available as ready to use kits.
For more information click: Medical Validation Kits.
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| Processor and architecture | Development Tools |
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