Page 48 - Safety Risk Management for Medical Devices

Requirements of the Risk Management Process 27

6.1.4 Risk control verification
See Chapter 22, Verification of Risk Controls, for a detailed discussion of verification
of Risk Controls.

6.1.5 Monitoring
Once the risk management process is completed and the product is released to the
market, it is required that manufacturers continuously monitor for how the
device is performing. This can take the form of surveillance, which is active
seeking of information. Or, complaint handling, which is the passive method of
receiving information. All collected information is to be used to update the
risk management work products as necessary. See Chapter 24, Production
and Postproduction Monitoring, for a detailed discussion of production and post-
production monitoring.