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Essential clinical performance

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Definition Edit

Medical device Edit

Essential clinical performance is

performance that is necessary to achieve freedom from unacceptable clinical risk, as defined by the manufacturer. Compromise of the essential clinical performance can produce a hazardous situation that results in harm and/or may require intervention to prevent harm.[1]

References Edit

  1. Postmarket Management of Cybersecurity in Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff, at 9.

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