Mr. George Calafactor

Mr. George Calafactor has decades of experience working in medical device regulation and compliance. He earned a BS in chemistry as well as metallurgical engineering from the University of Notre Dame, an MS in regulatory affairs at Northeastern University, and an MBA in international business at Indiana University. He is a certified quality biomedical auditor and a certified medical device investigator. He has served as a consultant of medical device regulation for numerous regulatory consultancies and worked as an international medical device investigator at the FDA for over 21 years. Currently, he is a regulatory consultant at both a consultancy firm in Indiana, where he a senior associate, as well as for numerous medical device manufacturers worldwide.