Swathi Samarasam

I am a certified ISO 13485 Lead Auditor and ISO 14971 Risk Management Specialist with over five years of experience in quality management, regulatory compliance, and medical device operations. I have led cross-functional teams and implemented QMS processes that improved compliance and operational efficiency.

At Trimed Solutions I implemented quality and compliance processes aligned with ISO 13485, conducted internal audits and risk assessments, and oversaw post-market surveillance and complaint handling for large device inventories. I supervised large technical teams and managed warranty/AMC/CAMC data for tens of thousands of medical devices while contributing to revenue planning and penalty control.

I hold an MBA in Hospital & Health System Management and a B.E. in Medical Electronics, and I am certified in EU MDR and EU IVDR. I bring a practical, process-driven approach to regulatory readiness, cross-functional stakeholder engagement, and continuous improvement.