Mary Vater is a Medical Device Consultant at Medical Device Academy. Mary earned her degree in Biomedical Engineering from Wichita State University. Prior to Medical Device Academy, Mary served time in both Engineering and Quality roles at Biomedical Devices of Kansas and was a Regulatory Strategist at Cerner Corp. At Medical Device Academy, Mary assists companies in both Quality and Regulatory assignments. Mary has worked on over 30 devices’ 510(k) clearances and has participated in countless Pre-Submission meetings with the FDA. Mary’s experience spans many different technologies including SaMD (Digital Health, Mobile Apps, AI/ML Contouring, Computer Aided Detection/Diagnosis/Triage), In Vitro Diagnostic Devices, Reprocessed Devices, Electromechanical Devices, Implants, Dental Products, Surgical Planning, Surgical Tools, and more. Mary is an expert in Medical Device Quality Management Systems and serves as interim Quality Manager for several of her early-stage start-up clients. Mary helped develop and teaches the AAMI 510(k)/De Novo and the Lead Auditor courses. In her free time, Mary enjoys camping and boating with her husband, baby son, and two dogs. At home, she can be found trying new recipes in the kitchen or tending to her chickens and garden.