Swathi Prabhakar Email & Phone Number

With over eight years of experience in quality and regulatory affairs, my primary interest lies in the intersection of product compliance and international standards, especially within the realm of medical devices. My expertise encompasses a broad range of standards, including IEC/EN 60601-1, specific to radiology and radiotherapy devices, CE marking, and compliance with MDD/MDR regulations. I am deeply engaged in ensuring adherence to EN/ISO 13485 as an internal auditor and ISO 14971 for risk management.qqqI am particularly interested in the challenge of navigating complex regulatory landscapes across diverse markets, including Brazil, Canada, Japan, Korea, Russia, ASEAN, CIS countries, and India (CDSCO MDR and ICMED). My role as a certified internal auditor for medical device QMS, EOHS, and ISMS, along with being an authorized PRRC, fuels my passion for maintaining high standards of quality and safety. I am dedicated to driving excellence in regulatory compliance and contributing to the successful global introduction of medical devices.

Listed skills include Medical Imaging, Medical Devices, Regulatory Compliance, Regulatory Documentation, and 5 others.