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DBuck.1
Associate
June 30, 2022
Question

In the process of finding a suitable MCU for a medical device, I find it hard to distinguish which of the MCU's are FDA approved and which ones not. Are there any especially good MCU's that are really robust and officially approved?

  • June 30, 2022
  • 2 replies
  • 1303 views

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    This topic has been closed for replies.

    2 replies

    Andrew Neil
    Super User
    June 30, 2022

    Do the FDA approve individual components, such as microcontrollers?

    Or do they just concern themselves with your overall product ... ?

    A complex system that works is invariably found to have evolved from a simple system that worked.A complex system designed from scratch never works and cannot be patched up to make it work.
    DBuck.1
    DBuck.1Author
    Associate
    June 30, 2022

    You are right, maybe I wasn't that clear with my question...

    My question is more about, if there are certain MCU's that are more used in medical devices, since they exhibit a robust performance. And if yes, which ones are these?

    I know this question is really vague, however there are almost too many possible MCU's, which make it hard to find one (or a type of MCU), that is like an "industial norm" for medical devices. Thanks a lot for your answer!

    Tesla DeLorean
    Guru
    June 30, 2022

    Most vendors explicitly exclude use in "life-critical" or military, weapons or manned flight applications. Sales into such spaces tend to require you to indemnify the vendor.

    Perhaps look to companies that specifically market devices into this space, rather than general purpose MCU/MPUs

    Most vendors have specific divisions into this market space, perhaps try LinkedIn

    https://www.google.com/search?q=medical+grade+mcu

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