In his six years with the FDA, Michael has reviewed well over 100 medical device premarket submissions (IDE, 510(k), PMA, DeNovo, and HDE) to determine if devices were safe and effective. A few of the premarket submissions Michael has reviewed include drug-eluting stents, atherectomy systems, percutaneous transluminal coronary angioplasty balloons, guide catheters, embolectomies, 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 the FDA for cardiovascular device systems and combination products, such as absorbable scaffolds, among others. Michael brings a wealth of knowledge, experience, and regulatory networking to Vision28.
Michael has a BS in Bioengineering and Chemistry from the University of Pittsburgh, and an MS in Biomedical Engineering from the University of Alabama at Birmingham. He has completed ISO 13485, AAMI Quality Systems, and Six-Sigma (Green Belt) training.