MCRA, LLC, a medical device and biologics advisory firm and clinical research organization (CRO) integrating US and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, and Quality Assurance, is pleased to announce the expansion of its neurological franchise. With the goal to support the company’s increasing focus on neurosurgery therapies, MCRA has hired Tim Marjenin as its new Vice President of Neurology Regulatory Affairs.
 
Tim joined MCRA from the US Food and Drug Administration (FDA), where he was Assistant Director of the Neurostimulation Devices Neurology Team. Tim’s extensive knowledge of medical device regulatory pathways to drive technology from conception to market is attributable to his many positions of leadership over his 16-year career at the FDA. In his most recent position, Tim led the Neurostimulation Devices Neurology Team, where he oversaw all regulatory decisions on PMA, IDE, HDE, De Novo, and 510(k) medical device submissions. He also functioned as a focal point for industry representatives, advisory panel members, scientific experts, and neurological thought leaders in this rapidly evolving device arena.
 
David Lown, President of MCRA said, “Since 2004, MCRA has progressed in becoming the most therapy specific, integrated, medical device CRO and advisory firm. This can only be accomplished with exemplary talent of which Tim most certainly is. Tim’s deep experience in all areas of neurological technology will provide enormous value to our clients and ultimately the patients who benefit from such innovations. I am positive Tim will make a tremendous impact to the industry as a whole.”
 
Tim Marjenin said, “Neurological devices are a rapidly growing medical technology segment that often combines implantable technology in combination with digital health care. It is a privilege to join the distinguished team at MCRA at such an exciting time in both neuro and MCRA’s evolution. I look forward to leading the MCRA neuro team to bring the next wave of innovative products and solutions to patients in need.”