Dr. Conway is responsible for all regulatory activities associated with IVD medical devices for Europe.
As Vice President, Anesthesia, Respiratory, & Sleep Regulatory Affairs, Mr. Courtney works closely with MCRA's Regulatory department to support medical device clients as they work to develop submissions to FDA at every stage, including through the total product life cycle. This includes the development of regulatory strategies, as well as performance testing, pre-clinical and clinical testing protocols, and the appropriate documentation intended to support market authorization.
Mr. Van Orden is a Mathematical Statistician with a clear understanding of the regulatory statistical requirements for study designs and statistical analysis plans. He has extensive experience in medical device clinical research in a wide range of device-areas, having presented before FDA/CDRH advisory panels for orthopedic, respiratory, neurologic, and aesthetic devices.
As Vice President of Spine Regulatory Affairs, Margeaux Rogers leads MCRA’s spine team in development of regulatory submissions, medical and regulatory writing, review and analysis of pre-clinical and clinical data, design of clinical trials, regulatory review of marketing materials, and regulatory strategy for medical devices.
At MCRA, Ms. Beck works closely with Sponsors in developing strategies to efficiently operationalize and de-risk clinical research studies in complex subject populations, on time and within budget.
With extensive knowledge of EU Notified Body and UK Approved Body operations including application, submission, conformity assessment, audit and decision making under EU and UK medical device legislation, Dr. Bowness focuses on EU/UK regulation, technical standards and Notified Body interactions, specializing in soft tissue reconstruction, guided tissue regeneration and associated implants and instruments.
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.
Ms. Schuman is responsible for overseeing the development and negotiation of clinical trial agreements and related budgets on behalf of study sponsors running clinical research managed by MCRA's Clinical Research Organization. Prior to joining MCRA in August 2010, Ms. Schuman worked at a small securities litigation firm as well as a special education law firm where she conducted research and drafted briefs in preparation for due process hearings on behalf of disabled students and their families. Ms.
Dr. McGowan leads MCRA's biologic, human cell and tissue, and combination product US regulatory affairs team, as well as contributing to MCRA's orthopedic and spine regulatory groups. Dr. McGowan's work at MCRA focuses primarily on novel technologies and therapeutics for which clinical data is necessary.
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.