STM32F4 based support for FDA class 3 medical devices...

[michaelfortner9]

Posted on June 13, 2013 at 23:45

Hello,

I have a new MCU customer in town that is looking for STM32F4-based information related to safety and robustness for medical applications within their Stem Cell production/separation device (FDA class 3 device).

I was wondering if we can provide any specific documents or links to information on 3rd party solutions as well as software libraries which may demonstrate our specific support for medical devices.

Mike

[Tesla DeLorean]

Posted on June 14, 2013 at 00:27

Avnet?

This is more of a user forum, such questions and tolerance for specific types of medical applications (life critical) are probably things you'd want to discuss directly with contacts within ST.

I would imagine third party libraries would be available from the usual vendors of such things. ST disclaims all ownership of responsibility for the regular libraries, ie you own all validation and liability if you use them. As such things go they are reasonably good, but they do have bugs here and there, and the example code is just that, and would need significant work to bring up to a commercial grade, especially in the area of error handling, propagation and recovery.

You might also want to look at the IEC 60335 Class B stuff and MISRA for robustness

http://www.st.com/st-web-ui/static/active/cn/resource/technical/document/application_note/CD00290100.pdf

[michaelfortner9]

Posted on June 14, 2013 at 05:59

I am being directed by the local ST folks to use the support forums to support this customer.

I appreciate the help Clive.  I will ask them for more guidance on the subject.