ESP32-D2WD vs ISO13485

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Joined: Wed Apr 07, 2021 8:19 am

ESP32-D2WD vs ISO13485

Postby PawBry » Wed Apr 07, 2021 11:06 am


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

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