Devjani Saha, Ph.D., Former U.S. Food & Drug Administration (FDA) Master & Lead Reviewer in the Office of Neurology and Physical Medicine Devices joins MCRA as Director, Neurology Regulatory Affairs.
WASHINGTON, October 5, 2021 /PRNewswire/ -- MCRA, LLC, a leading medical device, in-vitro diagnostic, and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Cybersecurity is pleased to announce Devjani Saha, Ph.D., Former Master & Lead Reviewer in the Office of Neurology and Physical Medicine Devices has joined MCRA as Director, Neurology Regulatory Affairs. Dr. Saha has 7+ years of experience in the FDA and 10+ years of clinical research experience in medical robotics and prosthetics. Dr. Saha has extensive knowledge of US regulatory processes associated with neurology and physical medicine devices.
Dr. Saha specializes in the review of medical exoskeletons, brain computer interfaces, physical rehabilitation devices including wearable technology, and early feasibility studies. While working at the FDA, Dr. Saha contributed to the development of the several policies and guidance, including the leapfrog guidance on brain computer interface, policies for the regulation of wearable devices for physical rehabilitation, and standards supporting exoskeleton testing.
Dr. Saha also served as the Early Feasibility Program representative and as a policy analyst for the Office of Clinical Evidence and Analysis with a focus on the Safer Technologies Program and Real-World Evidence. She also helped to launch the Safer Technologies Program (STeP) and provided programmatic expertise during the review of STeP submissions. STeP is a FDA program designed to expedite the review of medical devices and device-led combination products that have the potential to significantly improve safety of existing treatments and diagnostics for conditions/disease that are less serious than those that are eligible for the Breakthrough Devices Program.
Before joining the FDA, Dr. Saha was a researcher in the field of prosthetics and robotic technologies for rehabilitation. Dr. Saha also worked at Mako Surgical where she helped train clinicians and company personnel on the use of a robotic application for orthopedic surgery.
MCRA’s Vice President, Neurological Regulatory Affairs, Tim Marjenin said: “Dr. Saha has a great deal of passion and expertise, and we are excited that she has joined our team at MCRA. With her diverse background both within industry as well as at FDA, she is well-positioned to assist clients. The areas of exoskeletons, medical robotics, and especially brain-computer interfaces are advancing and evolving rapidly, and her knowledge will be invaluable to clients seeking to help patients with a multitude of diseases and conditions. MCRA Neuro strives to be at the forefront of innovation and the development of products to improve the lives of patients, and these devices represent important elements of that vision.”
Dr. Saha said: “It such an exciting time to be in involved in the field of neurology and physical medicine with cutting edge technologies designed to revolutionizing the way we think of treatment, diagnosis, and patient care. I’m incredibly honored to be joining such a talented group of individuals at MCRA and look forward to helping medical device companies bring safe and effective products to patients in need.”
About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics, and biologics advisory firm and Clinical Research Organization (CRO). MCRA delivers to its clients’ industry experience at integrating five business value creators: regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and serves more than 700 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, and in vitro diagnostic (IVD) devices as well as medical device cybersecurity. www.mcra.com
About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com
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