ISO14971
**ISO14971**
What is ISO14971?
ISO 14971 is an international standard that specifies requirements for a risk management system to minimize risks associated with medical devices. It outlines a process for manufacturers to identify hazards, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. It is commonly used by medical device manufacturers to demonstrate compliance with regulatory requirements and to ensure the safety of their products for patients and users.
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