MCRA's world class know-how and execution unlocks barriers, advancing our clients mission to better the availability of quality medical care to patients around the world.
Tim Marjenin
Overview
As Vice President, Neurology Regulatory Affairs, Mr. Marjenin works closely with MCRA’s Regulatory department to support medical device manufacturers as they work to develop submissions to FDA at every stage, from early concept to marketing applications. The includes the development of regulatory strategy, non-clinical, pre-clinical, and clinical testing protocols, and summary documentation intended to support market clearance or approval.