Maria DiBari is a consulting partner for 1SmartQMS LLC, helping companies bridge quality gaps, remediate compliance issues, and build out quality management systems from the ground up. With over 18 years of experience in medical device R&D and manufacturing, pharmaceutical manufacturing, and A.I. health software application development, she brings unparalleled expertise and a wealth of experience to the forefront. Maria brings a wealth of experience to medical device compliance, auditing, quality assurance, validation, and artificial intelligence. A graduate of the State University of New York-New Paltz, she holds a Bachelor of Science and a Master’s degree in molecular biology. She is a quality expert in the application of regulations such as 21 CFR Part 11, 21 CFR 820, and 21 Centuries Cures Act. As an executive leader in validation remediation, quality strategy development, strategic executive engagement, and team management, Maria provides guidance to executive management on the strategic development of health software applications. LinkedIn Profile: https://www.linkedin.com/in/mariadibariphelps

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