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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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News & Publications

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Press Releases

MCRA Leads Innovation Training with FDA as Part of its Experiential Learning Program (ELP)

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Nov — 2017
Press Releases

FDA Selects MCRA to Share Expertise as Part of the Experiential Learning Program (ELP)

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Sep — 2017
Press Releases

MCRA Releases New White Paper Analyzing the Industry Impact of the Federal Budget Request on FDA

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Jul — 2017
Press Releases

MCRA Advises Orthopedic Industry To Adopt Integrated Value Creation Strategy

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Jul — 2017
Publications

Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

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May — 2017
News

Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

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May — 2017
Press Releases

MCRA Expands, Moves to New DC Location

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Feb — 2017
Press Releases

SANUWAVE Health Submits de novo Petition for FDA Review and Classification of the dermaPACE System to Treat Diabetic Foot Ulcers

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Aug — 2016
Publications

Four Questions to Help You Avoid Losing a CE Mark

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Aug — 2016
Press Releases

MCRA Assists Cartiva, Inc. with Obtaining FDA PMA Approval for the Company's Synthetic Cartilage Implant (SCI)

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Jul — 2016
Press Releases

MCRA Assists VertiFlex, Inc. with Obtaining FDA PMA Approval for the Superion® Interspinous Spacer System

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Jun — 2016
Press Releases

MCRA Hires Experienced Trauma And Total Joint Expert To Expand Its Leading Orthopedic Regulatory Team

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Mar — 2016
Press Releases

MCRA Assists Wright Medical Group, Inc. with Obtaining FDA PMA Approvable Decision for Augment® Bone Graft

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Nov — 2014
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