Mehdi Kazemzadeh-Narbat

Mehdi Kazemzadeh-Narbat

Associate Director, Regulatory Affairs
Background

Dr. Kazemzadeh-Narbat is an associate director at MCRA, and former FDA medical device lead reviewer and acting team lead who has worked on a wide range of products through hundreds of FDA reviews. Beside his almost 5 years medical device regulation experience at FDA, he was also a consultant and subject matter expert for biocompatibility, chemical characterization and toxicological risk assessment, animal study and antimicrobial associated devices in the Agency. Dr Kazemzadeh-Narbat is experienced in approval processing and clearance of 510(K), PMA, De Novo, IDE, Q-submissions, Combination Products, Breakthrough device regulations and Clinical Evaluation Report (CER) submissions. Dr Kazemzadeh-Narbat is also a Biomaterials Scientist with experience in design and characterization of various biomaterials for Medical Products, and is experienced in in-vitro, ex vivo, and in vivo (Pre-clinical Animal Models). Dr. Kazemzadeh-Narbat has published multiple science, and regulatory papers and has developed two FDA Guidance documents (e.g., Google Scholar, ODT Bone Graft, ODT Antimicrobial).

Education

Dr. Kazemzadeh-Narbat received his Ph.D. in Biomedical Engineering from the University of British Columbia, Vancouver in 2012. He also received his MS, and BS in Biomedical Engineering from Iran. He is a certified Project Manager (PMP), certified Quality Assurance Auditor (CQA), certified for application of Risk Management to Medical Devices per ISO 14971 (BSI), certified for Quality Management Systems for Medical Devices per ISO 13485 (BSI), certified Biocompatibility Expert (NAMSA, and Wuxi AppTec), and certified for Animal Care (CCAC).

Experience

Prior to MCRA, Dr. Kazemzadeh-Narbat was a Scientific Lead Reviewer and acting Team Lead in the Center for Devices and Radiological Health (CDRH) for OHT1 (Dental Devices) and OHT6 (Orthopedic Devices). Before FDA, Dr. Kazemzadeh-Narbat was an R&D supervisor at Cook Biotech Inc. Prior to that, he was a postdoctoral fellow at Harvard-MIT Division of Health Sciences and Technology, and a postdoctoral fellow at Dalhousie University.

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