DINENISOMedical devices – Application of risk management to medical devices (ISO , Corrected version ); German version. Medical devices – Application of risk management to medical devices (ISO , Corrected version ); German version EN. A brief walk-through of ISO medical device risk management in plain English & overview of key definitions and concepts.
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This International Standard specifies a process for a manufacturer to identify the hazards 19471 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. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels.
ISO – Medical devices — Application of risk management to medical devices
This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management dinn. Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email.
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ISO 14971 and Risk Management
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