Michael Nilo

Michael Nilo

Nilo Medical Consulting Group, LLC
President and Principal Consultant

Categories covered by Michael

Talks covered by this speaker

30

FDA Today - EUA & SaMD

About this Speaker

Nilo Medical Consulting Group is a regulatory and quality consulting group focused on helping companies with medical devices and combination products. They also pride themselves in educating professionals, students, or other interested parties. The President, Michael Nilo is a biomedical engineer with 13+ years in the medical device industry, working at the FDA, for industry and as a consultant. He has hands-on familiarity with most functions and departments of a successful medical device company, and has provided consulting advice for verification and validation testing, quality systems, and regulatory submissions for different classes of medical devices. As a consultant, he has authored and submitted applications to FDA for Class II and III medical devices, and has extensive experience with Q-submissions, clinical trial development for medical devices, quality system regulations, and all manner of FDA interactions. Michael acts on the advisory board for several device companies and local incubators in the Pittsburgh region. He is the Capstone Director for undergraduate biomedical engineers at Duquesne University and a guest lecturer at University of Pittsburgh. He’s an effective regulatory affairs professional, public speaker, teacher, and problem solver. Prior to starting Nilo Medical Consulting Group, Michael worked in industry with international teams to develop regulatory and testing plans to meet FDA requirements. He authored and submitted pre-IDE, 510(k), HDE, IDE, and original PMA submissions to FDA for many cardiovascular device systems, including combination products such as drug-eluting stents and bioabsorbable scaffolds. Michael also worked at the FDA’s Office of Device Evaluation as a lead reviewer for both cardiovascular and dental devices. Additionally, he was part of many special interest working groups and policy development teams.

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