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Common QMS Mistakes SaMD Companies Make

Global Medical Device Podcast powered by Greenlight Guru

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Machine Learning Versus AI as a Medical Device

Machine learning versus AI is another thing that I think sometimes we get a little bit tripped up by and how you capture that. From a technical point of view, yes, but in terms of the scope of a QMS, whether the device is AI or not, doesn't really directly affect it. And again, as part of the regulatory framework, you know, you just can't keep changing your intended use all the time.

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