Michael Barile is the Founder and Managing Partner of Barile & Associates, Inc., a global life sciences consulting firm specializing in pre-market regulatory submissions, design, development, manufacturing, and post-market surveillance of life-saving technologies. Mr. Barile has over forty years of experience in the medical device, pharmaceutical, human tissue, and biotechnology industries. He has held executive quality assurance positions in start-ups and large multinational corporations, specializing in difficult turnaround situations. His depth of experience in both line and corporate management has given Mr. Barile a unique and practical hands-on expertise with a wide variety of challenges over a diverse range of product technologies. A recognized expert in risk management, software, process validation, continuous improvement methods, and quality systems, he lectures worldwide in seminars and for various trade groups.