Periodic Safety Update Report (PSUR) for Medical Devices
PSUR focuses on safety which needs to be updated timely, with investigation, observation and further studies to provide balance of risk-benefit profile of a product.
PSUR summarizes outcome of the post-marketing surveillance activities relating to safety and performance of device, setting out conclusions on the indicators followed and on significant events found. These events may be already identified and already followed up, they may also be new risks or benefits ultimately not achieved.
This Whitepaper Includes:
- History of changes
- Surveillance results (including clinical follow-up)
- Vigilance results
- Trend analysis
- Identification and verification of signals
- Benefit/risk analysis
