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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

Mar — 2020

MCRA Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic

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Jan — 2020

MCRA Strengthens Its Reimbursement, Health Economics, and Market Access Division with the Hiring of John D. McDermott, Jr., MBA

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Nov — 2019

MCRA Assists CorFlow in Obtaining Breakthrough Device Designation

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Nov — 2019

THINK Surgical and MCRA Announce 510(k) Clearance and US Launch of Revolutionary Total Knee Replacement Technology

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Nov — 2019

MCRA Strengthens its Cardiovascular and Digital Health Franchise with Hiring Former FDA Assistant Director Nicole Goodsell Batista

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Apr — 2019

MCRA Assists Intellirod Spine with 1st ever Spine De Novo Decision by the FDA

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Mar — 2019

MCRA Assists with Premarket Approval of the M6-C Artificial Cervical Disc - 1st Spine PMA Approved by the FDA in More than Three Years

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Mar — 2019

MCRA Hires FDA Interventional Cardiology Devices Branch Chief Michael John as VP of Cardiovascular Regulatory Affairs

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Feb — 2018

MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

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Jan — 2018

MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA

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Jan — 2018

MCRA Assists SANUWAVE with Successful De Novo Decision: 3rd Wound Care De Novo Since 2010

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Dec — 2017

MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

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The Journey Is Long, Pick The Right Partner

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