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ANSI/AAMI/ISO 14971:2007 (R2016)

Medical devices - Application of risk management to medical devices

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 requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.

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Association for the Advancement of Medical Instrumentation [aami]

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