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  • mb698 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 6 years, 6 months ago

    I agree with the error that risk management is not a life cycle process because it is not something which is at the last step instead it should be a continues process throughout the development of the device. Risk analysis meeting is important it is more than one meeting. Risk should not be relying on the historical data. Risk manager has to identify the risks in any product.