Incident Management with Precision.
When a serious adverse event occurs, timelines are tight. We assess reportability, draft the MIR/MDR, and submit to authorities within the mandatory deadlines.
Decision Trees
Not every complaint is an incident. We apply strict decision trees (MEDDEV 2.12/1) to determine if reporting is required.
Global Submission
One incident often requires reporting to multiple authorities globally. We handle the multi-jurisdictional reporting.
Root Cause Investigation
We guide your engineering team to perform a proper Root Cause Analysis (RCA) using 5-Whys or Fishbone diagrams.
Calm in the Storm.
Deadline Adherence
We ensure you meet the 15-day (or 2-day/10-day) reporting windows to avoid enforcement actions.
Correct Terminology
Using correct IMDRF codes for adverse events and device problems is critical for data analysis. We code it right.
Crisis Communication
We help draft the Field Safety Notice (FSN) if the incident leads to a recall.
Reporting Phase
Triage
Receive event info. Immediate assessment of severity and reportability.
Draft Report
Draft the Initial Incident Report (e.g., MIR, Adverse Event Report). Obtain medical review if needed.
Submit & Investigate
Submit initial report. Open CAPA investigation. Submit Final Report upon closure.
Outputs
Frequently Asked Questions
What is the deadline?
Changes by region, but generally: Serious Public Health Threat (2 days), Death/Serious Injury (10 days), Others (15-30 days).
Do you submit directly?
We prepare the file. For specific markets like Korea or US, we can assist with submission.
Can you train our team?
Yes, we offer Vigilance training workshops.