Risk Management is necessary when dealing with medical devices. Many companies have different ways of evaluating risk within a project such as using a pFMEA, FMEA or FMECA.
There are four main ways to manage a risk:
1. Mitigate
2. Transfer
3. Eliminate
4. Avoid
Give an example of a product risk and how you as an engineer would evaluate and manage that risk if you were apart of the project team.