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Listen "Is your State of Affairs for MDR State of the Art?"
Episode Synopsis
If you're struggling to determine whether your devices qualify as state of the art - and how that can impact your submission strategy - then check out this presentation I did with my friends at Greenlight Guru in August.
Etienne Nichols and I sort through all the acronyms - SOTA, SOC, MDR, MEDDEV, IVDR - and try to shed some light on what MDR says about state of the art, what it doesn't say, and how to determine your best path forward.
Etienne Nichols and I sort through all the acronyms - SOTA, SOC, MDR, MEDDEV, IVDR - and try to shed some light on what MDR says about state of the art, what it doesn't say, and how to determine your best path forward.
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