ISO 14971:2019
**ISO 14971:2019**
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.
Which job functions commonly mention ISO 14971:2019?
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