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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?

DBuck.1
Associate
 
3 REPLIES 3

Do the FDA approve individual components, such as microcontrollers?

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

DBuck.1
Associate

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!

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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