MCRA
Dr. Allen is a former FDA medical device reviewer with 5 years of experience in regulatory affairs. Dr. Allen has worked on a wide range of device types including cardiovascular, orthopedic, and plastic/reconstructive surgery devices. Dr. Allen is also a biocompatibility expert with extensive experience in biological evaluation including biological risk assessment, biological testing, hemocompatibility evaluation, chemical characterization, toxicological risk assessment, manufacturing-based rationales.
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MCRA
MCRA is a leading advisory firm and Clinical Research Organization (CRO) to medical technology developers. Core areas of expertise include regulatory, reimbursement, clinical research, healthcare compliance and quality assurance.