Michael Nilo

Speaking Session: There’s a Guidance for That! (Why following every FDA guidance document literally can still get you into trouble.)

Michael Nilo
President & Principal Consultant

Nilo Medical Consulting Group

Michael Nilo has worked in the medical device industry since 2009, including six years as a lead reviewer with the US FDA. He has consulted on verification and validation testing, quality systems, and regulatory submissions across device classes, and brings extensive experience in clinical trial development, quality system regulations, and FDA interactions. He is an effective speaker, teacher, editor, and troubleshooter with a strong foundation in physics, biochemistry, mechanobiology, and mathematics.

Before founding Nilo Medical Consulting Group, Michael was a Senior Regulatory Affairs Specialist at Biotronik, Inc., where he worked with international teams to build regulatory and testing plans for FDA requirements. He authored and submitted pre-IDE, 510(k), HDE, IDE, and original PMA submissions for many cardiovascular device systems, including combination products such as drug-eluting stents and bioabsorbable scaffolds.

At the FDA’s Office of Device Evaluation, Michael served as a lead reviewer in the Interventional Cardiovascular Devices Branch and the Dental Devices Branch. He reviewed premarket submissions for coronary devices, including drug-eluting stents, atherectomy systems, PTCA balloons, and guide catheters, as well as dental implants, abutments, bone-grafting materials, bone plates, and TMJ implants. He also served on numerous special interest work groups and policy development teams.