Manufacturers need to monitor their medical devices on the market because some trends may become visible only after market launch, when a device is used in larger groups of patients and follow-upperiods are longer.
Manufacturers need to
• establish a system for post-market surveillance to capture information on the use of their devices,
• plan their activities in post-market surveillance plans, and
• based on their plan, periodically document the results of their analyses in safety reports…
