Hi All,

Post Market Surveillance is simply the process of monitoring a device after it is part of the market. It includes many aspects of a medical device, like device failure. There are even requirements for some Class II and III medical devices to have required post market surveillance.

The main way that post-market surveillance can be carried out on a medical device is through the monitoring of device failure. At the previous company I worked with, any device that failed was sent back to the failure analysis lab. This allowed us to identify if the failure was a manufacturing error, user error, or if there was a problem with the device as a whole. This allowed for the monitoring of the device and ensuring that any device failures were not due to the safety or manufacturing of a device.

-Andrew Nashed

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm