Tag Archives: state of the art

SOTA

State-of-the-Art: Unpacking MDR’s Evolving Requirements

By Elisabeth Liljensten, Lina Burman, Mark Cabonce, M.S., DABT, Monica Grekula
SOTA

Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.

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Jane Chao, Ceribell
MEDdesign

The New ICU

By Jane Chao, Ph.D., Jason Siegel, M.D., Sayona John, M.D.
Jane Chao, Ceribell

The pace of innovation in the ICU is orders of magnitude slower than that of the cath lab and OR, and the COVID-19 crisis has pushed, tested, and exposed ICUs for lacking state-of-the-art technology and resources.

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