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  • fo3 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 8 years, 4 months ago

    In my opinion, I think a major mistake would be to assume that one is only looking for extreme and catastrophic risks and therefore overlooking risks that are also important. For example, there are risks due to safety that one may overlook and cause issues in the long run. There are business related risks that can be overlooked because one may be only determining risks due to device safety. It is important as a team to analyze the project from all angles and determine all impacts that device has on every area (business, production, etc).