ISO 14971:2019

The highlights of the updated risk management standard

Benefit: Positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health.

State of the art: Developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.

Reasonably foreseeable Misuse​: Intentional or unintentional use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behaviour.
Risk/benefit analysis​ is now called “Benefit-risk analysis”

Furthermore, minor changes have been made to other terms such as: accompanying documentation, harm, in vitro diagnostic medical device, manufacturer, and use error.

  • General

  • Information collection

  • Information review

  • Actions
Recommended actions
  • This method can include gathering and reviewing data and literature for the medical device being considered and similar medical devices on the market.

ISO 24971 suggests that some risk management activities can be performed by external consultants or specialists. Take a look at “Implementing an effective risk management process” to learn more about how Technolution’s risk management specialists can help you and your project.

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