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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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Case Studies

Case Study: MCRA Assists Pangea Laboratory to Achieve Breakthrough Device Designation

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Aug — 2025
Case Studies

Empowering FDA Clearance of United Imaging Intelligence Technology in Under 60 Days

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Jul — 2025
Case Studies

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

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Jul — 2025
Case Studies

Case Study: MCRA Assists Epiminder with FDA De Novo Approval for Minder, the First Implantable, Continuous EEG Monitor for Epilepsy

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Jul — 2025
Case Studies

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

Read Case Study
May — 2025
Webinars

Mastering Healthcare Transactions: A Strategic Approach to Compliance, Safe Harbors, and Regulatory Challenges - MCRA Webinar

Watch Mastering Healthcare Transactions Now.
May — 2025
Case Studies

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

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Apr — 2025
Case Studies

Case Study: MCRA Supports BONESUPPORT with FDA De Novo Clearance and Reimbursement Strategy for CERAMENT G

Read Case Study
Apr — 2025
Case Studies

Case Study: MCRA Supports CamDiab with FDA Approval for Artificial Pancreas Software

Read Case Study
Apr — 2025
Webinars

FDA Layoffs and the Impact to Industry - MCRA Webinar

Watch Webinar
Mar — 2025
Case Studies

Case Study: MCRA Supports Darmiyan with FDA Approval for BrainSee Device

Read Case Study
Mar — 2025
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