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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 medical 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. 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.
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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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| Software Products Real-time operating systems MMU RTOS File System CAN bus |
Test Environments Cantata RequisitePro LDRA Test Bed Rational Test Real Time |
| Processor and architecture
ARM 7/9/11 CORTEX A, R, M Coldfire V1, V2, V3, V4 TI and ADI DSP PPC - 4xx, 5xxx, 7xxx, 8xxx x86 RM, x86 PM 16-bit |
Development Tools ARM ADS, RVDS, Keil, IAR GHS Multi GNU and variants TI Code Composer IAR Metrowerks Wind River Compiler |
