Global Vigilance & Adverse Event Reporting
24/7 Rapid Response. When Every Hour Counts.
The Risk of 'Under-Reporting'
The most common trigger for an FDA Warning Letter or EU Notified Body finding is the failure to report a reportable adverse event within the strict regulatory deadline.
Decision Paralysis
Hesitating on whether an event is 'reportable,' causing critical deadlines for FDA, EU, or MFDS submissions to be missed.
Narrative Errors
Writing an initial incident report that inadvertently admits to a product defect before a full root cause analysis is complete.
Coding Mistakes
Using incorrect IMDRF adverse event codes, leading to data rejection by global databases like EUDAMED or GUDID.
The Leanabl Insight
Vigilance reporting is not just a regulatory burden; it is your first and most critical line of defense against an unnecessary or overly broad recall. A well-managed process protects both patients and your bottom line.
One Incident, Global Compliance
Our vigilance team handles the complex matrix of reporting forms, coding systems, and submission timelines across different global jurisdictions.
Korea MFDS (Safety Information)
We manage immediate reporting for events causing serious injury and coordinate with your importer on any necessary Field Safety Corrective Actions (FSCAs).
US FDA (MDR - eMDR)
Our experts handle Form 3500A drafting and submission via the FDA's electronic system, including 5-Day reports for high-risk events.
EU MDR (MIR & FSCA)
We author and submit the Manufacturer's Incident Report (MIR) form, manage trend reporting (Article 88), and coordinate FSCAs with your EU Rep.
The Decision Tree Protocol
We filter the noise, escalate the signal, and report with precision.
Leanabl Reporting Workflow
Event Occurs
Complaint, service ticket, or field report is received.
Serious Injury or Death?
Initial triage based on severity.
Immediate Report
/ Log & Trend
Your Complete Response Package
Regulatory Submissions
Timestamped proof of eMDR/MIR submission for your quality records.
Decision Justification
A formal rationale for every NON-reporting decision, ready for an auditor.
FSCA Strategy
Drafting of recall notices and Field Safety Corrective Action plans.
Why Trust Us in a Crisis?
IMDRF Coding Experts
Our team is fluent in the complex, hierarchical coding system now required by both the EU MDR and the FDA for harmonized event reporting.
Legal-Regulatory Balance
We craft reports that are transparent and compliant for regulators without creating unnecessary legal liability for your business.
Global Coordination
By managing reporting across the US, EU, and Asia, we ensure your data narrative is consistent everywhere, preventing discrepancies between agencies.
Don't Panic. Just Report.
Ensure you have a qualified rapid response team on standby before an incident occurs.
Contact Vigilance Team