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
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.
Enter your E-mail address. We'll send you an e-mail with instructions to reset your password.
