Mary Vater
Faculty @Aami
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WORK HISTORY
Faculty @Aami
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
SKILLS
ABOUT MARY VATER
Experienced Medical Device Quality and Regulatory Affairs Consultant with a history of…
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