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Main navigation
  • Services

    A unique integrated perspective for creating the optimal product pathway

    Learn More
    • Global Clinical Research Organization
    • FDA Regulatory
    • Medical Device Reimbursement
    • Healthcare Compliance
    • AI & Imaging Center
    • Global Regulatory
    • Quality Assurance
    • Talent Solutions
    • Cybersecurity Solutions
  • Therapy Specialization

    Deep Therapy Experience

    MCRA offers specialized therapeutic expertise across the full spectrum of medical devices and biologics. We help clients navigate the scientific complexities of healthcare innovations.
    Learn More
    • Orthopedics
    • Spine & Spinal Devices
    • Cardiovascular Devices
    • Wound Care & Dermatology
    • Biologics & Combination Devices
    • Neurology & Neurosurgical Devices
    • Anesthesia, Respiratory, Sleep & ENT
    • General & Plastic Surgery
    • Dental Devices
    • Imaging & Robotics
    • In-Vitro Diagnostics
    • Cell and Gene Therapy
    • Digital Health
    • Biocompatibility Services
  • Geographies

    Expand Your Healthcare Distribution With MCRA Global Access

    Our global approach integrates regulatory
    strategies across the top
    medical markets in the world.
    Learn More
    • United States
    • Europe
    • Japan
    • Other Global Markets
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Press Releases

Feb — 2023

MCRA Assists Medtrade with CELOX™ PPH CE Mark, Advancing Strategy and Time to Market

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Dec — 2022

MCRA Announces New Vice President of Reimbursement, Healthcare Economics, and Market Access

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Nov — 2022

MCRA Expands into Anesthesia and Critical Care Therapy Specializations, Hires FDA Assistant Director

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Oct — 2022

MCRA Expands European IVD Division, Hires Former BSI Global Head of IVD

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Oct — 2022

MCRA Expands Biostatistics Division with Key Hire of Former FDA Biostatistician

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Aug — 2022

MCRA Expands Recently Formed Biocompatibility Division with 2 Key Hires from FDA and Industry

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Jul — 2022

MCRA Assists NeuroMetrix with Obtaining FDA Breakthrough Device Designation and Marketing Authorization in One Year

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Jun — 2022

MCRA and Clients Achieve Significant Milestone - Over 60 Breakthrough Device Designations Granted by FDA

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Jun — 2022

MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA

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Jun — 2022

MCRA Assists Net Health in Receiving Breakthrough Device Status

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Mar — 2022

MCRA Acquires Vorpal Technologies K.K. to Further Expand its Global Advisory Services in Japan

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Jan — 2022

MCRA Assists Active Life Scientific with Clinical Study Execution and Successful De Novo Decision for the OsteoProbe - A New Tool to Measure Bone Tissue

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The Journey Is Long, Pick The Right Partner

MCRA's world class know-how and execution unlocks barriers, advancing our clients mission to better the availability of quality medical care to patients around the world.

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IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry dedicated to delivering actionable insights. Learn more at www.iqvia.com.

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