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Unlocking Excellence: Quality at the Core

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  • ISO 14971

    Understanding ISO 14971: Comprehensive Guide to Risk Management for Medical Devices

    eLeaP Editorial Team

    November 13, 2024

    18 min read

    Understanding ISO 14971: Comprehensive Guide to Risk Management for Medical Devices

    Abstract ISO 14971 is one of the most widely accepted standards that offer a coherent process for managing medical device risks. This paper aims to evaluate the incidence of risks, regulatory provisions, and risks to patients concerning the entire lifecycle of a device. It also includes an extensive examination of procedures for assessing and controlling […]

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