ANSI/AAMI/ISO 14971:2007/(R)2016

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ANSI/AAMI/ISO 14971:2007/(R)2016

Medical devices - Application of risk management to medical devices.

Summary: This risk management standard 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.

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14971

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