> For the complete documentation index, see [llms.txt](https://opora.gitbook.io/opora-health-documentation/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://opora.gitbook.io/opora-health-documentation/adverse-event-reporting.md).

# Adverse Event Reporting

The **Adverse Event Reporting** enables real-time tracking and reporting of adverse events, ensuring quick identification and response. This feature allows users to document incidents with detailed context, including the nature of the event, involved individuals, and any immediate actions taken. Reports are securely stored and linked to audit trails, supporting compliance with regulatory requirements such as the EU Medical Device Regulation (MDR) and Good Clinical Practice (GCP). 

![](https://lh7-rt.googleusercontent.com/docsz/AD_4nXdPUKUXt1tDnhHYxJdZc3icqhj_Emma52nrNd0MA5NYge4Zp5QBpg4z6rqMjkGpYYNj-Cbe_QsM4H2_o0B7tMbmh9Lv3CXq1YPlugnayGf1_cOYaMcXuUY4sml3B2B5-zlxCAoVnesGgHw8jtZnrMdWqUynuzG3EeOLtz5xEQ?key=ELetpOvU9kAE0-eawm7y1w)