Teams at Imricor Medical Systems

Support post-market surveillance by ensuring timely global medical device reporting, performing trending analysis, managing the complaint database, leading product complaint investigations, authoring PSURs and surveillance plans, supporting regulatory inspections, and training staff on complaint reporting.

Ensure safety, effectiveness, and regulatory compliance of marketed medical devices through post-market data collection, analysis, trending, complaint investigations, reportability assessments, CAPA support, PSUR and post-market surveillance reporting, risk management per ISO 14971, health hazard evaluations, audit support, and implementation of corrective actions to improve product performance and patient safety.

Support and maintain a compliant quality management system for medical devices, including CAPA, nonconformance management, audits, document/change control, training, metric analysis, root cause investigations, and cross-functional collaboration to ensure regulatory compliance and continuous improvement.