Mary Vater is an experienced Medical Device Quality and Regulatory Affairs Consultant, currently focused on AI/ML Software as a Medical Device. With a Bachelor of Science in Bioengineering from Wichita State University, they have assisted over 30 companies in achieving Quality and Regulatory goals, resulting in numerous FDA clearances, CE marks, and Quality Management System certifications. Mary has held various roles, including Head of Quality Assurance and Quality Assurance and Regulatory Affairs Consultant, and currently teaches courses at AAMI to advance knowledge within the medical device industry.
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