Post-Market Crises Require Immediate, Expert Defense.
Clearance is Just the Beginning of Regulatory Scrutiny.
Failing to report adverse events or establish Corrective and Preventive Actions (CAPA) within strictly regulated timeframes can result in immediate market removal and heavy fines.
Rapid Adverse Event (AE) Reporting
We provide immediate triage of product failures or patient injuries, formulating and submitting scientifically robust incident reports to the MFDS within the mandatory 7, 15, or 30-day windows.
PMS & Re-evaluation Execution
We design compliant protocols and fully manage the data collection and final reporting for your mandatory Post-Market Surveillance (PMS) or ad-hoc MFDS Re-evaluations.
CAPA & Recall Mitigation
When a field action is unavoidable, we negotiate the scope with regulators and build bulletproof CAPA justifications to minimize operational disruption and prevent total product recalls.
Defending Commercial Viability During Crises.
Critical AE Defense
Scientifically proved that a severe adverse event involving a high-risk device was caused by clinical user error rather than a product defect, averting an imminent MFDS sales suspension.
Large-Scale PMS Success
Successfully coordinated and submitted a deeply complex 3-year PMS data package for a Class III implant, preserving the client's permanent commercial license.
Protect Your License. Protect Your Patients.
When an incident occurs, the clock is ticking. Rely on our rapid response team.
Set Up Vigilance MonitoringFrequently Asked Questions
Common queries about medical device vigilance and PMS.