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  • dipanpatel replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 7 years, 4 months ago

    I also agree with the 4th example being a very important aspect of risk management. When a company conducts it own identification of risks and test they try to be very thorough. However, a company cannot identify all risk and issues which can arise with the product under various unknown circumstances. Therefor processes like change orders address and issue and hopefully by solving the issue lead to a better project. I also agree that the rick management should remain very active especially when changes are made, because this change may solve the first problem but it can lead to undiagnosed risk factor that could have been checked but were overlooked.