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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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Press Releases

Jun — 2024

MCRA Supports CamDiab with FDA Approval for Artificial Pancreas Software

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Jun — 2024

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

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Jun — 2024

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

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May — 2024

MCRA Announces Record Success in Supporting Orthopedic Innovation

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May — 2024

MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with OstaguardTM Coating

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May — 2024

MCRA Supports Darmiyan with FDA Approval for BrainSee Device

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Apr — 2024

MCRA Supports Bone Health Technologies with De Novo for OsteoBoost

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Mar — 2024

MCRA’s Head of Healthcare Compliance to Serve on Michigan Board of Medicine

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Feb — 2024

MCRA Announces the Hiring of FDA Statistician for Diagnostic Devices

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Feb — 2024

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

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Jan — 2024

MCRA Provides Anzu Special Acquisition Corp I with Strategic Diligence Support Leading to Envoy Medical Merger (NASDAQ: COCH)

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Jan — 2024

MCRA Announces European Expansion

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