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Anthony Monaco replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
I definitely agree that having multiple risk assessments along the development process is essential. Along with this, however, I think it is also very important that that risk analysis meetings are more than just one meeting. By this I mean, one can’t expect to think of all of the possible risks in a single meeting; even if a group of people are providing their input. I personally don’t have experience with how actually companies do their risk assessment, but I feel the most effective way to get a majority of the risks from the start would be to have a couple meetings a couple days apart. This gives the brain time to come up with more ideas that may have not been thought of earlier. In general, however, coming up with risks should never be limited to designated meetings.