MCRA is pleased to share a webinar presented by Mehdi Kazemzadeh-Narbat, Ph.D., CQA, MCRA's Senior Associate, Regulatory Affairs, on the topic of "Considerations for Orthopedic Implant Associated A
MCRA, LLC partnered with LSX to present a webinar on Navigation MDR Expectations for Tomorrow Based on Notified Body Feedback Today, as part of a webinar series.
MCRA, LLC partnered with LSX to present a webinar on Medical Device Materials: The US and EU Biocompatibility Regulatory Landscape.
MCRA, LLC partnered with LSX to present a webinar on Digital Health US Market Pathways: Navigating an Evolving Regulatory Framework.
MCRA, LLC partnered with LSX to present a webinar on Wound Care Innovation: The Call to Clinical Action.
At MCRA, Dr. Allen develops and executes regulatory strategies for medical product clients. His work includes 510(k), Pre-Submission, Investigational Device Exemption (IDE), Premarket Approval (PMA), and Clinical Evaluation Report (CER) submissions for MCRA’s medical product clients. Dr.
Mr. Aguel has more than 16 years of regulatory affairs experience. He specializes in developing and refining regulatory strategies for Heart Failure and Circulatory Support devices. Including development of regulatory submissions, interacting with the FDA, clinical trial design, and review and analysis of pre-clinical and clinical data.
WASHINGTON, May 20, 202
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