Michelle Rubin-Onur
Regulatory Mentor @Plug and Play
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WORK HISTORY
Regulatory Mentor @Plug and Play
EDUCATION
Baylor College of Medicine
Doctor of Philosophy (PhD), Integrative Molecular and Biomedical Sciences
University of St. Thomas (TX)
Bachelor of Arts (B.A.), Biology/Biological Sciences, General
ABOUT MICHELLE RUBIN-ONUR
Wow that was such a great experience\" is a comment I often hear after an engagement between a client and FDA. I help medical device companies conduct regulatory due diligence, interact with FDA, and go through the authorization process quickly and painlessly. I work with med device companies at all stages, from companies just starting with a picture on the napkin to companies that already has FDA authorization. Past clients include companies that are looking for FDA feedback during device development, companies submitting premarket submissions and companies that need quality management documentation of device changes. I offer a variety of services:🟦 Premarket support 🟦 Postmarket support🟦 Business strategyLet\'s talk! m•••••••@aetheriumregulatoryconsulting.com
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