The purpose of this paper is to elaborate the importance of ISO 14971 – medical devices risk management standard, in the medical world. Beginning w ith a succi nct introduction, the paper. ISO specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The purpose of this paper is to elaborate the importance of ISO 14971 – medical devices risk management standard, in the medical world. Beginning w ith a succi nct introduction, the paper. Risk management is a structured application of policies, procedures, and practices for analyzing, evaluating, and controlling risk. ISO 14971 is both a framework and informative guidance designed specifically for medical device manufacturers to use in developing and maintaining a risk management system.
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