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SMann.1250
Associate
Nov 15, 2019 10:37 AM UTC
Solved

Is this tool approved by various medical standards

I am trying to understand whether or not I would have to get this tool approved under the medical standards we must adhere to for a class B type medical device.

The standards are

IEC 62304

ISO 13485

This topic has been closed for replies.
Tesla DeLorean
Tesla DeLoreanBest answer
Guru
Nov 17, 2019 4:57 PM UTC

A cursory review of the forum should indicate that CubeMX fails to meet basic industry QA standards/expectation.

The parts also aren't sold into circumstance were failure, or normal usage, might result in death or injury.

You should engage with ST sales directly.

Tips, Buy me a coffee, or three.. PayPal Venmo (See Profile) Up vote any posts that you find helpful, it shows what's working..

4 replies

RMcCa
Senior II
Nov 15, 2019 12:51 PM UTC

Please ask a vaguer question.​

SMann.1250
Associate
Nov 17, 2019 4:31 PM UTC

rich1 ...If you can't understand the question please just do not involve yourself.

Tesla DeLorean
Tesla DeLoreanBest answer
Guru
Nov 17, 2019 4:57 PM UTC

A cursory review of the forum should indicate that CubeMX fails to meet basic industry QA standards/expectation.

The parts also aren't sold into circumstance were failure, or normal usage, might result in death or injury.

You should engage with ST sales directly.

Tips, Buy me a coffee, or three.. PayPal Venmo (See Profile) Up vote any posts that you find helpful, it shows what's working..
SMann.1250
Associate
Nov 17, 2019 7:08 PM UTC

Makes sense looking at the standard of the code generated by CubeMX. Many thanks