What is ISO 14971?

ISO 14971 is a ten-part standard that defines the risk management process for medical devices and in vitro diagnostics-including software as a medical device (SaMD). The standard is recognized by international medical device regulators as the best practice for identifying hazards, estimating risks, developing risk controls, verifying the effectiveness of those controls, and monitoring postmarket surveillance data for changes in the risk of your device. The 2019 version of the standard is the most recent version of the standard, and there is a new guidance document that was released in 2020 that you will need to use with ISO 14971:2019.
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[@yeyos5]

Thank you. Very informative.

[@MedicalDeviceAcademy]

You are welcome!

[@TeW33zy]

Actually I am a Principle Design Assurance Engineer and I would like to correct something about Risk Management. Actually the purpose of ISO 14971 is to eliminate unnecessary risk.

[@MedicalDeviceAcademy]

I'm not sure we can say that an internal standard has only one purpose. I'm sure Edwin Bills (one of the authors) could list of multiple reasons why we need ISO 14971 (e.g., it is a foundational tool for documenting how electrical safety is ensured for electromedical devices in IEC 60601-1).