Emergo

Emergo by UL is a leading global consultancy specializing in regulatory affairs, quality assurance, and clinical services for the medical device and in vitro diagnostic (IVD) industries. The company provides end-to-end support for manufacturers, including global regulatory strategy, Quality Management System (QMS) implementation, and market access services in over 25 countries. Following its acquisition by UL in 2017, Emergo has expanded its capabilities to include human factors engineering, usability testing, and specialized clinical research organization (CRO) services for medical technologies. The firm is a key partner for companies navigating complex compliance landscapes such as the EU MDR/IVDR and FDA 510(k) submissions. Its expertise spans from digital health and software as a medical device (SaMD) to complex hardware and diagnostic platforms.