Closing the loop: post-market surveillance and vigilance
A product on the market is a product still being watched. Post-market surveillance is how real-world experience becomes safer products — and it is where many quality systems fall short.
By MoniDoseQMS Team
Approval is not the finish line. Once a device or medicine is in use, regulators expect manufacturers to keep listening — to gather real-world data, detect problems early, and act. Under EU MDR this is post-market surveillance and vigilance, and it is one of the areas where weak, disconnected systems show their cracks most clearly.
Gathering the signals
- Complaint handling and customer feedback
- Adverse event reporting and field safety notices
- Recall management when action is needed
- Post-market surveillance, PMS evaluations, and PSUR
- PMCF plans, reports, and evaluation reports for ongoing clinical follow-up
Turning signals into action
The point of surveillance is not to collect data — it is to act on it. In MoniDoseQMS a complaint can drive a CAPA, a CAPA can drive a change, and a change can update the technical documentation and risk file. The loop closes, and the next version of the product is safer because of what the field taught you.
Post-market surveillance is the promise that you will keep watching after the sale — and that is exactly what patients are trusting you to do.