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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
    • Statistical Analysis for Medical Devices
  • 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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News & Publications

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Press Releases

MCRA Hires Former Leader of FDA Breakthrough Device Program & Neurology Division Manager

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Oct — 2020
Press Releases

MCRA CRO Assists Simplify Medical, Inc. on the Fastest Spine PMA Ever Approved by the FDA

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Oct — 2020
Press Releases

MCRA Expands Neurology Franchise with Hiring of Tim Marjenin, Former FDA Assistant Director

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Aug — 2020
Press Releases

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

read article
Mar — 2020
Press Releases

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

read article
Jan — 2020
Press Releases

MCRA Assists CorFlow in Obtaining Breakthrough Device Designation

read article
Nov — 2019
Press Releases

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

read article
Nov — 2019
Press Releases

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

read article
Nov — 2019
Publications

MedTech Strategist - Hot Topics in Cardiovascular Devices with Michael John

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Jun — 2019
Publications

The Role of New Technology in Chronic Pain Management

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May — 2019
Press Releases

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

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Apr — 2019
Press Releases

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

read article
Mar — 2019
Press Releases

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

read article
Mar — 2019
Case Studies

Recent MCRA Spine PMA Case Study Success

read article
Jul — 2018
Brochures

Clinical Research Organization

read article
Jul — 2018
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