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VP, Quality and Regulatory Affairs
Gerald Palecki is the Principal at Palecki Enterprises, a consulting practice specializing in medical device Quality Assurance and Regulatory Affairs.
Gerald has more than 25 years experience developing and managing medical device quality assurance/regulatory affairs systems; both FDA Quality System Regulation and ISO 13485, for development, manufacture, and distribution of a broad range of medical devices. Prior work includes laser surgery and therapy systems, brain activity imaging systems, orthopedic implants, and respiratory therapy/pulse oximetry devices.
Mr. Palecki’s medical device related activities include preparation and filing of FDA premarket notifications for product clearance to market and corresponding communication with FDA during the application review process.
His background also encompasses development of electronic systems for deep space communication at NASA’s Jet Propulsion Laboratory.
He has a BA in Biology from California State University, Los Angeles and an Associate Degree in Electronics.
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