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ISO 14971:2019

Last updated May 17, 2025, generated by Sumble

What is ISO 14971:2019?

ISO 14971:2019 specifies procedures for the manufacturer to identify 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 14971:2019 are applicable to all stages of the life-cycle of a medical device. It is commonly used by medical device manufacturers to demonstrate compliance with regulatory requirements for risk management and to ensure the safety of their products for patients, users, and other individuals.

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What other technologies are related to ISO 14971:2019?

ISO 14971:2019 Complementary Technologies

ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It's complementary to ISO 14971:2019 as it provides a framework for quality management that supports the risk management process outlined in ISO 14971.

mentioned alongside ISO 14971:2019 in 8% (95) of relevant job posts