MCRA, an IQVIA business

MCRA, an IQVIA business, is a specialized Clinical Research Organization (CRO) and consulting firm focused exclusively on medical devices, diagnostics, and biologics. The firm works with more than 850 companies annually on over 1,700 projects, providing integrated services from innovation conception through commercialization. Their practice areas span FDA regulatory consulting, global clinical research, reimbursement strategy, quality assurance, and emerging areas like AI/imaging and cybersecurity for medical devices.

The firm maintains deep therapy specialization across 14 areas including orthopedics, spine, cardiovascular, neurology, wound care, digital health, and in vitro diagnostics. Their team includes former FDA reviewers with extensive experience in device categories ranging from spinal systems to imaging equipment. MCRA provides global regulatory support covering U.S., European, and Japanese markets, with particular expertise in navigating complex pathways like De Novo applications, IDE studies, and PMA submissions.

Recent case studies demonstrate the firm's capability in accelerating device clearances, including FDA clearances achieved in under 60 days and support for first-in-class device authorizations. Their integrated approach combines regulatory, clinical, reimbursement, and quality expertise to address the full product lifecycle for MedTech companies.

Choose MCRA when you need regulatory expertise grounded in real FDA experience, particularly for complex or first-in-class medical devices requiring sophisticated regulatory pathways. Their former FDA reviewers understand agency expectations and can craft strategies that anticipate regulatory concerns. The integrated model is particularly valuable when your device requires coordinated regulatory, clinical, and reimbursement planning to ensure not just approval but market viability.

Expect a consultative partnership with access to therapy-specific experts who understand your device category deeply. The firm's scale allows them to handle everything from small 510(k) submissions to large-scale IDE trials, while their IQVIA backing provides additional resources for global expansion when needed.

MCRA operates exclusively in the medical technology sector, focusing on devices that directly impact patient care across multiple healthcare settings. Their work spans hospital-based capital equipment (imaging, surgical robotics), implantable devices (orthopedic, cardiovascular, neurostimulation), point-of-care diagnostics, and emerging digital health hardware. The firm's expertise addresses healthcare-specific regulatory frameworks including FDA device classifications, EU MDR requirements, and PMDA processes in Japan.

Their reimbursement practice (RHEMA) specifically addresses healthcare payment models, working on coding strategies, coverage policies, and health economics to ensure devices achieve not just regulatory approval but market access. The healthcare compliance expertise addresses Anti-Kickback Statute, Stark Law, and other healthcare-specific legal considerations for medical device manufacturers.

The ideal MCRA client is a medical device, diagnostics, or biologics company with a physical product requiring FDA clearance or international regulatory approval. This includes venture-backed startups developing innovative Class II or III devices, growth-stage companies conducting pivotal clinical trials, and established manufacturers launching new product lines or entering new markets. Companies benefit most when they need specialized regulatory expertise combined with clinical trial execution or require integrated support across regulatory, reimbursement, and quality domains.