Background
Dr. Akhlaghi is an electrical and computer engineer with demonstrated regulatory, scientific and project management skills, recognized for strong work ethics and high sense of initiative. As a scientist, he has developed expertise in Artificial intelligent/machine learning, data analytics, study design, simulation, signal and image processing. As a former FDA medical device lead reviewer, he developed a deep understanding of regulatory requirements, processes, and deadlines in the medical device and Digital health fields. He specializes in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), AI/ML-based devices/functionalities, Image Acquisition and/or optimization Guided by AI, Computer Aided Devices including Detection, Diagnosis, Triage, Notification and (CADe, CADx, CADe/x, CADt,), Predetermined Control Plans and Ultrasound Imaging/instrumentation.
Education
Dr. Akhlaghi received his Ph.D. in Electrical and Computer Engineering specializing in Biomedical Imaging from George Mason University in Virginia. He also received his BS and MS degrees in Physical and Biomedical Electronics from Kyiv Polytechnic Institute, and Sumy State University, Ukraine, in 2009 and 2010.
Experience
Dr. Akhlaghi provides regulatory affairs strategy, technical writing, oversight, and project support services to MCRA Digital Health and Imaging clientele. His responsibilities include developing and executing regulatory services including: regulatory submissions (510(k), IDE, Q-sub, Breakthrough, and PMA); regulatory strategy, analysis, and development; as well as design, review, and implementation of pre-clinical testing.