Oliver Eikenberg Ph.D., Emergo by UL, Senior Consultant QA/RA
Oliver has over 17 years of medical device regulatory experience combined with technical hands-on experience in device development, manufacturing, and product management. Oliver’s analytical chemistry experience, combined with many years producing immunoassays, informs his expertise in in vitro diagnostic devices.
Oliver focuses on medical device regulations in the EU and the US, including Quality Management System implementations. Oliver's areas of expertise include 510(k) submissions, 513(g) requests, Q-Sub (Pre-Sub) meetings with FDA, and multiple Technical Files for CE-marking in the EU for medical devices and IVDs.