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Risk Management (ISO 14971)

What is the ISO 14971?

ISO 14971 specifies terminology, principles, and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

Who is ISO 19471 for?

The Medical Devices Regulation (MDR) (EU) 2017/745In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746  and as less as FDA’s 21 CFR Part 820 include the requirements for risk management.

ISO 14971 represents the state-of-the-art for risk management for medical devices and therefore it can be used to demonstrate conformity to the regulatory requirements.

ISO 14971 applies to risks associated with a medical device but it can also be applied to products that are not necessarily medical devices in some jurisdictions and be used by others involved in the medical device life cycle.

ISO 14971 does not apply to:

  • decisions on the use of a medical device in the context of any particular clinical procedure or
  • business risk management.
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