| Medical device manufacturers go to great pains to place products on the market; vast resources are expended on planning, designing, and testing devices prior to end-user distribution. Despite this significant time and resource commitment, devices are often released with safety or quality problems. The Food and Drug Administration (FDA) has been tasked by Congress to ensure that manufacturers of medical devices perform post-market vigilance activities. Every year, many companies fail to properly implement these requirements and are cited by the FDA. This thesis examines relevant documents, books, and articles to identify FDA post-market requirements for the evaluation of customer complaints, investigation of device malfunctions, medical device reports, Corrective/Preventative Actions (CAPA), and field corrections or removals. The thesis also provides guidance for manufacturers of medical devices to help them implement a post-market quality assurance program that enhances safety, drives product improvement, and ensures regulatory compliance. |
