EN ISO 14971:2016

Risk analysis is a tool for the evaluation of potential problems which could be encountered in connection with the use of any number of things related to the medical device. We live in a world full of risks, with varying likelihoods and consequences. Risk analysis is now routinely used during the design phase for medical devices.

Why should we perform risk analysis?

  • Risk analysis is now required by law
  • Identification of device design problems prior to distribution eliminates costs associated with product recalls.
  • It offers a measure of protection from product liability damage awards.
  • Regulatory submissions for CE Marking, FDA 510k etc.
  • It is the right thing to do.

The origins of the inclusion of risk analysis are real incidents of harm to the patients receiving treatment by medical devices, such as electric shocks, over-infusion by infusion pumps, and over doses of radiation. Too many of these incidents resulted in the deaths of patients.

This International Standard EN ISO 14971:2012 specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical devices, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control.

The requirements of ISO 14971 International Standard are applicable to all stages of the life cycle of a medical device.
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