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  • andria93 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 6 years, 6 months ago

    I do agree with you guys that risk management meeting or job is not a stage of the project, It goes all allow from the beginning to the end and sometime even after the product is out to the market as Dr. Simon mentioned in our last meeting. Also, I think everything in risk management should not be based on predictions, However more no true input and analysis. Also, I disagree that We assume that risk can be measured by standard deviation, especially when it is based on older data. Standard deviation used more for finance as a measure of investment risk and shouldn’t be used in risk management. I believe this is one of the common mistake or wrong methodology to depend on it.