An example for managing the risk for a medical device:
There is a medical device called “PEMF: Pulsed ElectroMagnetic Field”, this device is being used for bone simulation (bone healing).
In terms of risk management, for example, risk of Toxicity, this could happen because PEMF stimulates cell metabolism functions. These functions include releasing toxins to be removed by your immune system. Cleansing crisis happens when the immune system becomes overloaded by detoxifying the body too fast and after measuring the risk, I found it is a high severity risk, in order to do Risk Mitigation, the patient should drink a large glass of water after each treatment to help the body flush the toxins.
So, now the severity of the measured risk reduced from high to low, to be accepted by QM.