---
bio: I am a Medical Device Quality and Regulatory Affairs consultant with a history
  of working on diverse products within the medical device industry. I have supported
  510(k) clearance for over 30 different medical devices, and have helped dozens of
  companies achieve their Quality and Regulatory goals. My 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. My technical background is in engineering product development with
  a degree focused in Biomedical Engineering.
hire_date: '2024-04-29'
hobbies: Camping, Watersports, Cooking, Teaching
linkedin: null
name: Mary Vater
photo: /img/people/Mary_Vater-640a02cde1d34ab395f92c3853ce7d53.jpg
skills: FDA Submissions, Regulatory Strategy, Quality Management Systems, Auditing,
  AI/ML SaMD
testimonials: []
title: Director of Regulatory Affairs
---