Navigating the Global IVD Landscape
Hear from Industry Experts in the U.S., Europe, and Japan on key regulatory and clinical trends around the world
James Mullally, Ph.D., Vice President, IVD Regulatory Affairs, US, MCRA
Former FDA Assistant Director, Chemistry and Toxicology Devices Division
Erica Conway, Ph.D., Vice President, IVD Regulatory Affairs, Europe, MCRA
Former Head of Notified Body - IVD at BSI
Samuel Pollard, General Manager, Vorpal Technologies, K.K. (a MCRA subsidiary)
10+ years leading global regulatory submissions
Julie Martel, Ph.D., Vice President, IVD Clinical Affairs, MCRA
25+ years IVD Clinical Experience
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MCRA is the leading industry-specialized CRO and integrated advisory firm that assists clients through the entire technology life cycle, from strategic planning through commercialization.
MCRA's regulatory team, which includes many former FDA Branch Chiefs and reviewers with combined agency and industry experience in the areas of cardiovascular, orthopedics, neurology and digital health, provides best in class regulatory strategy support.
MCRA's reimbursement team works with many early stage companies to define and execute successful US reimbursement and market access strategies across all medical devices.
MCRA's full service CRO can fully manage clinical studies, beginning with study design and protocol development, or provide support to companies as they take lead in study execution.
The MCRA team provides services to a wide range of organizations in the healthcare industry, including start-ups to the world's leading healthcare organizations.
The full suite of integrated advisory services helps augment internal capabilities and processes, as well as ensure the ability to overcome regulatory and reimbursement hurdles while collecting the necessary clinical evidence.
www.mcra.com
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