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Avinash Donthula is working as Senior QARA Specialist at NIRAMAI focused on obtaining US FDA clearances for NIRAMAI’s solutions. He has 10+ years of medical devices regulatory compliance and quality assurance experience ranging across multiple product domains like interventional radiology, orthopedics, heart assist devices and SaMD. His expertise is in the area of FDA, CE regulations, QMS, Quality engineering, auditing etc. He previously worked for Varian Medical Systems, DePuy Synthes Switzerland, Cordis Corporation and HCL Tech. He holds an M.Tech degree in Clinical Engineering from Indian Institute of Technology, Madras.