MCRA Hires Former Leader of FDA Breakthrough Device Program & Neurology Division Manager
• 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 CRO Assists Simplify Medical, Inc. on the Fastest Spine PMA Ever Approved by the FDA
- 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 Expands Its Medical Device Digital Health and Cybersecurity Franchise with the Hiring of Jason Tugman
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.
MCRA Expands Neurology Franchise with Hiring of Tim Marjenin, Former FDA Assistant Director
WASHINGTON, Aug.
Jason Tugman
Overview
Mr. Tugman works closely with both MCRA’s Regulatory and Quality Assurance departments, to support medical device manufacturers as they work to develop secure technology, analyze device security control measures, and to also implement robust security policies which are necessary to gain market access.
John McDermott
Overview
At MCRA, John leads projects that focus on coding, coverage, payment, evidence generation, and value communication strategies. He provides guidance on Medicare and managed care payment strategies as well as on developing and executing launch plans for new products. He also works closely with commercial and clinical development teams on strategies to make clinical trials and observational research commercially compelling.