Process documentation for FDA cleared devices

Innolitcs blogs:

Our AI development process includes generating reports that detail the input data, model performance, and model selection process. These reports streamline model development by helping developers recognize and correct some of the most common pitfalls in algorithm development, thereby increasing confidence in the AI/ML algorithm’s safety and efficacy. As a convenient side effect, these reports are a powerful tool when designing a QMS suitable for AI and navigating the FDA clearance process.

I am not endorsing their “process” but it is a whole field of regulatory science. Someone has to “comply” with the “regulation”. Neither, I am endorsing this company. I stumbled on this from some source and decided to link it here because it merits some consideration on how the regulatory process untangles itself- because the algorithms have a potential for real harm.