Mary Vater

About Mary Vater

Experienced Medical Device Quality and Regulatory Affairs Consultant with a history of…

Experience

1. Faculty

   Aami

   Oct 2019 — Present

   Developed Lead Auditor, Post-Market Surveillance, 510(k), and De Novo training courses for the non-profit organization founded to advance knowledge within the medical device industry- Teach attendees compliant best practices in the areas of ISO 13485 and 21 CFR 820 auditing- Teach attendees about the 510(k) and De Novo Process. Explain the different sections of the submissions including the device description, substantial equivalence, electrical safety, EMC, biocompatibility, sterilization, software, animal testing, benchtop performance testing, and clinical testing.

Education

• Wichita State University

  Bachelor of Science (B.S.), Bioengineering

  2009 — 2013

Skills

• Communication
• Medical Devices
• Capa
• Risk Management
• Team Management
• Technical Writing
• Product Development
• Quality Assurance
• Aseptic Technique
• Written & Oral Presentation Skills
• Quality Control
• Microsoft Excel
• Powerpoint
• Research
• Project Management
• Agile Methodologies
• Engineering
• Microsoft Powerpoint
• Iso 13485
• Design Control
• Program Management
• Highly Detail Oriented
• Leadership
• Data Analysis
• Aseptic Processing
• Testing
• Microsoft Office