About
MCRA is a global medical device, diagnostics and biologics CRO and consulting advisory firm offering regulatory, clinical research, quality assurance, reimbursement and compliance services. Since 2004 MCRA advises across clinical trial stages (site qualification to post commercialization) and provides FDA regulatory consulting and international regulatory affairs support. Its Compliance Services are designed to support healthcare organizations and medical device companies with corporate compliance programs. The firm also provides cybersecurity services for medical devices including risk assessments and advisory, and operates an AI & Imaging Center to support radiologic AI/ML studies aligned with regulatory expectations. MCRA additionally offers talent solutions and market access advisory for MedTech and life sciences clients.
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