MCRA is pleased to announce its role in the successful Premarket Approval (PMA) application decision by the U.S.
MCRA is pleased to announce its work with Medtrade on obtaining the CE Mark for its CELOX
Medical device companies rely on our quality assurance consulting for medical devices to meet or exceed the standards set by the FDA and other regulatory bodies. Our strong experience working with regulators and Notified Bodies helps to guide you through the processes for product review, approval, and regulatory compliance.
John joined MCRA on August 31st, 2020 as Senior Director, Neurology Regulatory Affairs. At MCRA, John provides guidance on regulatory strategies and submissions development for MCRA’s neurology clients, as well as interacts on breakthrough device designation submissions and strategies across various therapies.
Mr. John manages and directs the MCRA Cardiovascular Regulatory Affairs department. Mr. John leads the firm’s submission process and global regulatory strategy for MCRA, which encompasses all aspects of the FDA approval process from non-clinical testing to clinical trial design and submission of the marketing application.
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.
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.