WASHINGTON, May 9th, 2024/PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is honored to announce its role in propelling innovation in the orthopedic industry through the involvement in more than half of all Orthopedic De Novo's issued by the U.S. Food and Drug Administration.
This impressive record is indicative of the exemplary expertise of MCRA’s renowned team. To date, the US FDA has granted a total of 14 orthopedic De Novo’s, 8 of which were for MCRA clients, including the first ever orthopedic De Novo ever granted back in 2017 for IlluminOss Medical. MCRA continues to provide superb value to clients, from conception to commercialization, and is pleased to have supported more than half of the orthopedic De Novos that have been granted.
Glenn Stiegman, Senior Vice President, Clinical, Quality & Regulatory Affairs, states “MCRA’s Orthopedic team is known worldwide for its exceptional track record and ability to help clients achieve their goals. Our De Novo success record is yet another reason clients trust MCRA with its regulatory needs. We are delighted to be such a top player in the orthopedic medical device industry.”
Anthony Viscogliosi, CEO of MCRA states, “MCRA has long been known for its exceptional work in the orthopedic space. This achievement, led by the exemplary Orthopedic experts at MCRA, shows our ability to work closely with clients and the FDA to bring new orthopedic innovations to the healthcare industry.”
