An example that I dealt with on a team at work was on a hemostatic agent that we were releasing. The testing that we conducted with the contract lab suggested that there would be potential risk associated with the endotoxin levels in the hemostatic mesh that was in the process of being launched. The teams initial thought was to accept the risk as it would not be a large issue since the FDA stance was currently on guidelines and not hard set rules against endotoxin levels. However, the way the guidelines are being shaped it does seem inevitable that eventually these guidelines will be more than just suggestions and needed to be implemented into medical device products. We instead chose to mitigate the risk by the addition of a process step that would reduce the endotoxin levels within the hemostat. This process took longer and did increase costs of the project however it may have saved more in the long run as we don’t have to worry about retroactively changing the product for that specific problem. On a side not I think the 4 risk management strategies are actually (mitigate,transfer, accept (not eliminate), and avoid).