Hello,
One of our clients wants to use ESP32-D2WD (Xtensa) for medical products. To pass the certification we need to have the tooling validated according to ISO13485. We using the ESP32 SDK: ESP-IDF v4.0.
The first question is if anyone knows that exist certified (medical) version of xtensa-none-eabi or other certified toolchain?
The second question is if ESP-IDF SDK is certified for medical devices or if there is any alternative?
Best Regards