adverse-event-reporter

# Adverse Event Reporter Skill ## Purpose The Adverse Event Reporter Skill supports adverse event monitoring and regulatory reporting for medical devices, ensuring compliance with FDA MDR requirements and EU vigilance obligations. ## Capabilities - MDR reportability assessment - FDA Form 3500A population assistance - MEDWATCH submission guidance - EU vigilance reporting templates - Trend analysis and signal detection - PSUR data compilation - Field safety corrective action templates - Complaint coding (MedDRA) - Risk assessment updates - Corrective action tracking - Regulatory notification timelines ## Usage Guidelines ### When to Use - Assessing adverse event reportability - Preparing regulatory reports - Conducting trend analyses - Managing field actions ### Prerequisites - Complaint information received - Investigation completed - Device information available - Regulatory requirements identified ### Best Practices - Assess reportability promptly - Document decision rationale - Track reporting timelines - Integrate with risk management ## Process Integration This skill integrates with the following processes: - Post-Market Surveillance System Implementation - Clinical Evaluation Report Development - Medical Device Risk Management (ISO 14971) - EU MDR Technical Documentation ## Dependencies - FDA MAUDE database - EUDAMED system - MedDRA coding dictionary - Complaint management systems - Risk management databases ## Configuration ```yaml adverse-event-reporter: ...