I had the experience of sitting in on a couple of risk analysis meeting, and this is early in the process when the team are trying to determine if the project is a go or no go. This prevent the company from spending too much time and money on a device or project to then deem it too dangerous or risky. As some of you have mentioned, these meetings and analysis are done by a team and not just one person, however, they do pull in feedback from different areas like clinical, marketing, development, etc. I have never had the opportunity to follow this process from start to end, but it’s always interesting to see how companies handle certain risk.