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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
    • AI & Imaging Center
    • Statistical Analysis for Medical Devices
    • Biocompatibility Services
    • Cybersecurity Solutions
    • Global Regulatory
    • Europe Regulatory
    • Japan Clinical and Regulatory
    • Quality Assurance
    • Healthcare Compliance
    • Talent 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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News & Publications

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Press Releases

MCRA Announces the Hiring of New Director of Patient Access Program Operations

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Dec — 2023
Press Releases

MCRA Announces Launch of Integrated AI & Imaging Center

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Nov — 2023
Press Releases

MCRA Announces the Hiring of Former FDA Leadership to Advance its Regenerative Medicine Expertise

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Nov — 2023
Press Releases

MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device

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Oct — 2023
Press Releases

MCRA Assists Ceribell with Obtaining FDA Breakthrough Device Designation, FDA Marketing Authorization, and CMS NTAP Reimbursement for ClarityPro Device

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Sep — 2023
Press Releases

MCRA Assists Procept BioRobotics Establish Reimbursement Listing in Japan

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Sep — 2023
Press Releases

MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon

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Aug — 2023
Press Releases

MCRA Expands Biocompatibility Division with Key Hire of Board-Certified Toxicologist

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Jul — 2023
Publications

Challenges within the European MedTech Market: How MCRA’s Experts Stand Out

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Jul — 2023
Press Releases

MCRA Announces Foundational Sponsorship of the AAOS OrthoPitch Technology Competition

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Jul — 2023
Publications

UKCA and CE Transitions for IVD Medical Devices: Planning is Key

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Jul — 2023
Press Releases

MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System

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May — 2023
Press Releases

MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Porous PEEK Cervical Interbody System

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Apr — 2023
Press Releases

MCRA Assists TriReme Medical with Obtaining FDA Premarket Approval of Cardiovascular Balloon Catheter

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Feb — 2023
Press Releases

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

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Feb — 2023
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