Post-Market Surveillance (PMS)
What is post-market surveillance (PMS)?
Post-market surveillance is how a medical device manufacturer monitors its device(s) while on the market. With PMS, manufacturers generate, collect, analyze, and respond to information on how the device is used and performs in the real world.
From the collected data, PMS can:
- Accurately understand how the device is used while it is on the market
- Discover safety issues with the design or use of the device
- Gather data for the future production of iterations or new devices
- Gather clinical evidence on device use to improve the product or services
In addition to the above actions, PMS is a required process by regulators, as devices must be followed for their entire lifecycle, which includes their time on the market.
How does post-market surveillance (PMS) improve healthcare?
While clinical trials are conducted to evaluate a device’s safety and efficacy, PMS allows a manufacturer to see how their device is used and functions in a real-world setting. By collecting this data, manufacturers can make adjustments based on how their device performs and use the data to ensure that the device continues producing the results seen during the clinical trial.
PMS is a crucial element of quality assurance, as evaluating the data can allow professionals to note weak areas—before they become a problem—and correct them.