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medical class A

Mauro Fantina
Genius 3800 points

Hello,

it is possible to use Concerto device with TI-RTOS mounted on M3

for a medical device developed in accordance to CEI EN 62304 for class A ?

 

Thankyou

  • 0
    TI__Expert 5560 points

    TI-RTOS does not meet any certification standards and we generally can't provide collateral like design documentation and extensive test suites to assist certification efforts. See the announcement at:

    http://e2e.ti.com/support/embedded/tirtos/f/355/t/313154.aspx

    However, my understading is that class A device have the lowest safety requirements and don't require design documentation and only limited testing evidence. If that is correct (and please check with your certification experts), then you may be OK using TI-RTOS. If there is a possibility that your application may go to a class B or class C, then I'd recommend going with an RTOS with a clear path to safety certification like SafeRTOS.