ISO 14971
Medical Devices - Application of Risk Management to Medical Devices
ISO 14971 is an international standard for manufacturers of medical devices. It specifies a process through which the manufacturer can identify hazards associated with medical devices including in vitro diagnostics (IVD) medical devices, to estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of the controls. The requirements of this standard are applicable to all stages of the lifecycle of a medical device.
This is only an overview/extract of the standard. Users should not rely on its accuracy, but should refer to the complete standard of the appropriate revision.
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