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Medical Device Usability as a Factor in Reducing Error and Improving Outcomes, Sagentia Consultants Suggest


4/4/2011 8:09:57 AM

MTB europe -- The new set of human factors standards that were introduced in 2010 (HE75, the new ANSI/AAMI standard and the IEC62366) aim to address the high number of medical device incidents that involve usability issues. By requiring companies to track user feedback and justify proposed use error mitigation approaches, regulators are emphasising the important role that usability plays in product safety.

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