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Standards Updates: Risk Management for Medical Devices

What’s New in ISO 14971:2019 and ISO/TR 24971:2020 Author: Silas Minnick, Senior Quality Engineering Consultant What’s in your ISO 14971 risk management plan? In December 2019, the latest revision to ISO 14971 was released. This standard specifies the terminology, principles, and processes related to the application of risk management for medical devices. While medical device…
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