(from RAPS, December 2019)

The International Organization for Standardization (ISO) unveiled its revised standard on the application of risk management to medical devices, giving more attention to the benefits expected from devices, as well other clarifications and additions from the previous version.

The revised standard, known as ISO 14971:2019, replaces the second edition from 2007 and introduces several new definitions on the terms “benefit,” “reasonably foreseeable misuse” and “state of the art.”

Read more here.