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RTOS/CC2640R2F: Is BLE Stack certified for medical Class III applications?

Kalyan Venkatraman
Prodigy 80 points
Part Number: CC2640R2F


Tool/software: TI-RTOS

Referring to one of the posts regarding the TI RTOS (see link below), there was one statement "TI does not allow many of its hardware or software products to be used in FDA Class III applications". 

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

Does this include TI RTOS as well?

Since bluetooth stack uses TI RTOS, does TI recommend using the bluetooth stack in FDA Class III applications?

  • 0
    TI__Guru** 105180 points

    Hello,

    The TI BLE stack and BLE wireless MCUs are used in many different applications, including medical, however, TI does not "certify" the protocol stack for any particular application. Since I"m not an expert in FDA Class III requirements, I'm unfortunately unable to make a recommendation. I do encourage you to review the product information with your compliance organization.

    Note that for CC26xx, the TI BLE Stack uses TI-RTOS.

    Best wishes