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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 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
Webinars

Navigating the Road to Successful Market Access: Health Economic Strategies for Medtech Innovators

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May — 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
Publications

Artificial Intelligence - A Literature Review's Best Frenemy

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Feb — 2023
Press Releases

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

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Dec — 2022
Publications

Compliance Flash: Holiday Compliance & Privacy

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Nov — 2022
Press Releases

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

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Nov — 2022
Press Releases

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

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Oct — 2022
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