Michael Nilo

As a Senior Regulatory Consultant at Vision28, Michael Nilo brings a wealth of knowledge, experience and regulatory networking. In his six years with FDA, Michael has reviewed well over 100 medical device pre-market submissions (IDE, 510(k), PMA, DeNovo and HDE) to determine if devices were safe and effective. A few of the pre-market submissions Michael has reviewed include drug eluting stents, atherectomy systems, percutaneous transluminal coronary angioplasty balloons, guide catheters, embolectomy, dental implants, abutments, bone-grafting materials, bone plates, and trans-mandibular joint implants. He has an excellent grasp of what FDA reviewers are looking for in all submissions. In private industry, he has developed successful regulatory strategies and authored/submitted pre-IDE, 510(k), HDE, IDE and original PMA submissions to FDA for cardiovascular device systems and combination products (e.g., drug eluting stents and absorbable scaffolds).

Michael has a Master of Science in Biomedical Engineering from the University of Alabama at Birmingham, and graduated from the University of Pittsburgh, with a Bachelor of Science in Bioengineering and Chemistry.