Post-market surveillance involves which primary activity?

• A. Only initial design validation
• B. Marketing analysis
• C. Supply chain risk assessment only
• D. Collecting and acting on information about device performance and safety after launch

Answer: (D)

Post-market surveillance is the ongoing process of monitoring a medical device after it reaches the market, collecting real-world data on how the device performs and whether any safety concerns arise, and then acting on that information. This means gathering reports from users and clinicians, analyzing trends in performance and adverse events, and implementing changes such as updated labeling, instructions for use, or corrective actions to reduce risk. It’s about lifecycle management after launch, not activities done before release like initial design validation or exploring market fit. Supply chain risk assessment focuses on procurement and manufacturing risks, not on post-launch performance in users, so it doesn’t describe ongoing surveillance of device safety and performance.