ISO 14971:2007, Medical Device Risk Management System 

ISO 14971:2007 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.

ISO 14971 is a risk management standard for medical devices. Its purpose is to help manufacturers to establish a medical device risk management process that they can use to identify hazards, to estimate and evaluate risks, and to develop, implement, and monitor the effectiveness of risk control measures

  • Implement ideal methods of reducing risk for all stakeholders
  • Develop devices and therapies that are proven effective in the industry
  • Manage speed and cost to market
  • Optimize speed of iteration
  • Streamline the regulatory process that will enable entry to selected markets

The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.


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