MCRA

MCRA provides integrated clinical research organization and advisory services across regulatory affairs, clinical trial operations, reimbursement and market access, healthcare compliance, cybersecurity, quality assurance, toxicology/biocompatibility consulting for medical devices and combination products. They are recognized for supporting innovation in the medical device industry globally. Now part of IQVIA’s portfolio ("an IQVIA business"), it provides comprehensive services spanning regulatory strategy/execution both domestically and internationally—including U.S., EU/Japan distribution logistics—as well as reimbursement strategy/access support, quality systems/compliance guidance including cybersecurity expertise. Its biocompatibility division offers end-to-end toxicology/risk assessment solutions led by former FDA experts. With offices across Washington DC HQ plus Hartford CT/New York NY/Tokyo Japan locations—and nearly one thousand clients worldwide—it plays an influential role especially within orthopedic innovation/regulatory pathways at FDA.