Michael Nilo, MS BME

Michael has 10 years of experience in the medical device industry, including direct experience with FDA device review processes and intricacies. 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. He authored and submitted applications to FDA for Class II and III medical devices, and has extensive experience with clinical trial development for medical devices, quality system regulations, and all manner of FDA interactions. He’s an effective public speaker, teacher, copy editor, and troubleshooter with a strong foundation in physics, biochemistry, mechanobiology, mathematics, and written language.

Prior to starting Nilo Medical Consulting Group, Michael worked as a Senior Regulatory Affairs Specialist at Biotronik, Inc., where he worked 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 in both the Interventional Cardiovascular Devices Branch and the Dental Devices Branch. He examined pre-market submissions for cardiac medical devices, specifically devices that are inserted into the coronary arteries and the devices used in the interventional procedure (e.g. drug eluting stents, atherectomy systems, PTCA balloons, and guide catheters). He also reviewed dental devices such as implants, abutments, bone-grafting materials, bone plates, and trans-mandibular joint implants. Additionally, he was part of many special interest work groups and policy development teams.

For more information, please see his LinkedIn profile.