Nexalin Technology, Inc. announced the appointment of Carolyn Shelton as Senior Vice President of Clinical, Quality & Regulatory Affairs on October 14, 2024. Shelton brings over 30 years of experience in the medical device industry, with expertise in regulatory compliance, quality assurance, and clinical development. Her role will involve overseeing all clinical studies, quality systems, and regulatory submissions.
Shelton's career includes leadership positions at Openwater Health, LLC, Advanced Sterilization Products, Inc., and Medtronic, where she managed global regulatory strategies and achieved compliance with regulations such as the EU MDR. Her experience includes preparing regulatory submissions like 510(k), PMA, and Breakthrough Device designations.
This appointment is crucial for Nexalin as it prepares to pursue global regulatory clearances and future FDA Breakthrough Device designations for its Deep Intracranial Frequency Stimulation (DIFS) technology. Her leadership is expected to be invaluable in driving the company's growth and innovation by navigating complex regulatory processes both in the U.S. and internationally.
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