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  • tilak replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 7 years, 8 months ago

    I don’t agree with this reason. For an effective product design, I believe risk management and design controls should occur in parallel to one another. That way risks can be identified in each step of a design and fixed immediately. The second reason is true. The reason most companies fail to effectively assess risk is because it is approached as another task that needs to be checked off rather than a way to improve product design. In terms of reason three, I believe FMEA and risk management are both necessary in improving over all product design. Finally, risk management should be a never ending process. New risks can always arise even when a product goes out for production.