John joined MCRA on August 31st, 2020 as Senior Director, Neurology Regulatory Affairs. At MCRA, John provides guidance on regulatory strategies and submissions development for MCRA’s neurology clients, as well as interacts on breakthrough device designation submissions and strategies across various therapies.
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.
• MCRA has hired Dr. John Doucet, Former US Food and Drug Administration (FDA) Policy Lead, Breakthrough Device Program as Senior Director, Neurology Regulatory Affairs.
- MCRA's CRO assisted Simplify Medical with the management of the clinical study, including leading data management, Clinical Events Committee (CEC), and monitoring support for the successful PMA a
MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) is pleased to announce the expansion of its digital health and cybersecurity franchise.
WASHINGTON, Aug.
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