ISO 14971: “Medical devices – Application of risk management to medical devices”

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. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device. he risk management process presented in ISO 14971 includes:

  • Identifying hazards and hazardous conditions associated with a medical device that could place patients or healthcare workers at risk.
  • Estimating the potential occurrence of such risks, and evaluating the extent of the consequences.
  • Developing and implementing active safeguards within the device or the production process to control risks.
  • Regularly reviewing and monitoring the process to assess the effectiveness of risk management controls and the risk management process.

Each aspect of a risk management system is thoroughly documented to provide evidence of the manufacturer’s commitment to control risk throughout the entire life of a given medical device design. A robust risk management system can also provide important value by supporting the development, production and distribution of all types of new medical devices. Products under development are subject to greater scrutiny early in the design stage. This allows for the identification and implementation of changes and modifications to improve functional safety and usability with minimal impact to the product development schedule. For certain types of medical devices, an effective risk management evaluation will also identify risks associated with device reprocessing and reuse. These and other benefits can result in faster time to market, and greater competitive advantages.

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