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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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  • Case Studies

Case Studies

May — 2025

MCRA Leads the Way: Empowering Synergy Spine Solutions with Comprehensive Regulatory, Clinical, and Healthcare Compliance Solutions Worldwide

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Apr — 2025

MCRA Assists SANUWAVE with Successful De Novo Decision for only the 3rd Wound Care De Novo Approved between 2010-2018

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Feb — 2025

MCRA Supports 3D Systems with 510(k) FDA Clearance for VSP PEEK Cranial Implant Device

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Jan — 2025

MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System

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Jan — 2025

MCRA Supports Onkos Surgical with First FDA De Novo Approval for Antibacterial Coating for Implants

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Mar — 2024

Case Study: MCRA Assists Australian Company Epiminder with FDA Breakthrough Designation for Epilepsy Monitoring Technology

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Jul — 2018

Recent MCRA Spine PMA Case Study Success

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Feb — 2018

MCRA Reimbursement Case Study

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The Journey Is Long, Pick The Right Partner

MCRA's world class know-how and execution unlocks barriers, advancing our clients mission to better the availability of quality medical care to patients around the world.

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IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry dedicated to delivering actionable insights. Learn more at www.iqvia.com.

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