Adverse Event Alerts
If any adverse events related to your device are detected, you’ll be notified within 48 hours, allowing for swift action.
Literature Review
We develop tailored literature search strategies using PubMed, Embase, and Google Scholar to gather the latest published information on your device and similar products. Our reports include the reviewed literature and a concise summary, giving you clear insights.
Public Adverse Events Reporting
We conduct thorough checks across all relevant regional databases where your device is sold, identifying and reporting any adverse events or risks associated with it.
Delivery
Your team will receive a monthly report summarizing and highlighting new data from our monitoring efforts, with a comprehensive quarterly summation provided every three months. This report serves as valuable input for Post-Market Clinical Follow-Up (PMCF) Evaluation, Post-Market Surveillance (PMS), or Periodic Safety Update Reports (PSUR).