Gokce (Gilly) Yildirim is a medical device professional with 17 years of experience directly related to research, development, regulatory, and quality applications. Gilly received his bachelor’s degree in industrial engineering from NJIT, Master of Science in Biomedical Engineering and MBA from Columbia University. Gilly has worked on medical devices ranging from medical robotics to additive manufactured implants with metals, plastics, and biologics, supporting development efforts with regulatory strategy, financial models, and medical standards authorship. Gilly has published numerous peer-reviewed articles and is a reviewer for several journals. Gilly is knowledgeable and has filed 14 510(k), 1 IDE, 1 IND, and 1 NIOSH approval document. Gilly also has 12 published or granted patents in the medical device hardware and software industry.