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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 Assists NeuroMetrix with Obtaining FDA Breakthrough Device Designation and Marketing Authorization in One Year

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Jul — 2022
Publications

Compliance Flash: Physician Owned Distributorship

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Jul — 2022
Press Releases

MCRA and Clients Achieve Significant Milestone - Over 60 Breakthrough Device Designations Granted by FDA

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Jun — 2022
Press Releases

MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA

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Jun — 2022
Press Releases

MCRA Assists Net Health in Receiving Breakthrough Device Status

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Jun — 2022
Publications

Compliance Flash: Single Use Devices

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Jun — 2022
Press Releases

MCRA Acquires Vorpal Technologies K.K. to Further Expand its Global Advisory Services in Japan

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Mar — 2022
Publications

Risk Management is critical to establishing a positive benefit: risk profile and ensuring the best possible patient outcomes. By: Peter Bowness Director, International Regulatory Affairs

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Jan — 2022
Press Releases

MCRA Assists Active Life Scientific with Clinical Study Execution and Successful De Novo Decision for the OsteoProbe - A New Tool to Measure Bone Tissue

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Jan — 2022
Press Releases

MCRA Assists Multiple Clients with Successfully Obtaining CPT Codes and Hospital Payment Reassignments

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Jan — 2022
Press Releases

MCRA Neuro CRO Division Strengthened

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Nov — 2021
Press Releases

MCRA Expands International Regulatory Team

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Nov — 2021
Press Releases

MCRA Expands Neurology Division into Medical Robotics, Exoskeletal and Brain Computer Interface Market

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Oct — 2021
Press Releases

MCRA Expands Neurology Division into Neurointerventional Market

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Sep — 2021
Press Releases

MCRA Expands In-Vitro Diagnostic Device Expertise

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Jul — 2021
Webinars

Considerations for Orthopedic Implant Associated Antimicrobial Agents: Regulatory Science

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Jun — 2021
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