Medical device manufacturers need to identify the hazards associated with their products in order to estimate, evaluate and control the associated risks and monitor the effectiveness of the controls. ISO 14971 provides guidance for the application of risk management for medical devices.
Compliance with the requirements of ISO 14971 third edition will be required under the newly published IEC 60601-1 3rd edition Amendment 2. Additionally, the U.S. Food and Drug Administration (FDA) has granted Recognized Consensus Standard status to the third edition of ISO 14971 already.
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