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Aniket Khakhadiya is a highly experienced regulatory affairs professional with expertise in medical devices and diagnostics. Currently serving as a Principal Regulatory Affairs Specialist at EBR Systems, Inc. since July 2024, Aniket has previously held similar positions at Pulmonx Corporation and Natera, demonstrating a strong track record in 510k, IDE, and PMA submissions to the FDA, as well as new medical device submissions to Health Canada. Aniket has also contributed to regulatory compliance and quality management systems at companies such as Abbott and COSMED USA Inc. The educational background includes a Master of Science in Medical Devices and Diagnostic Engineering from the University of Southern California and a Bachelor of Engineering in Biomedical Engineering from Vidyalankar Institute of Technology.