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…