Case study — Post market product monitoring system

Medical device manufacturers are responsible for ensuring that their medical products are safe, reliable and effective. In case of product deficiency, malfunction, or notification of patient harm; medical device manufacturers need to be able to track all devices and recall them if required. To have the ability to do this, they need to have a robust post market product monitoring system. Food and Drug Administration (FDA), which is responsible for protecting the public health by assuring the safety and effectiveness of medical devices, requires medical device manufacturers to have a well defined post market surveillance program that includes post market surveillance studies as well as adverse event reporting. This paper discusses all the elements of a robust post market surveillance program i.e. product monitoring system, using a practical example.