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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
    • AI & Imaging Center
    • Healthcare Compliance
    • Statistical Analysis for Medical Devices
    • Biocompatibility Services
    • Global Regulatory
    • Quality Assurance
    • Talent Solutions
    • Cybersecurity Solutions
    • Europe Regulatory
  • 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

Oct — 2025

Case Study: Fasikl Receives FDA Clearance for Felix NeuroAI™ Wristband, the First and Only AI-Powered Treatment for Essential Tremor

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Sep — 2025

Case Study: MCRA Assists ReGelTec with IDE Approval for HYDRAFIL, the First Pivotal US Clinical Trial Approved for Nucleus Pulposus Augmentation

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Sep — 2025

Case Study: MCRA Assists Evaheart’s Pivotal COMPETENCE Trial in Support of the EVAHEART®2 LVAS

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Aug — 2025

Case Study: MCRA’s Regulatory and Reimbursement Team Helped Move icotec Through Commercialization

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Aug — 2025

Case Study: MCRA Helps Rescue a Clinical Study That Previous CRO Mismanaged

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Aug — 2025

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

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Jul — 2025

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

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Jul — 2025

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

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Jul — 2025

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

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May — 2025

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

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Apr — 2025

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

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