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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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Publications

MedTech Strategist - Hot Topics in Cardiovascular Devices with Michael John

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Jun — 2019
Publications

The Role of New Technology in Chronic Pain Management

read article
May — 2019
Press Releases

MCRA Assists Intellirod Spine with 1st ever Spine De Novo Decision by the FDA

read article
Apr — 2019
Press Releases

MCRA Assists with Premarket Approval of the M6-C Artificial Cervical Disc - 1st Spine PMA Approved by the FDA in More than Three Years

read article
Mar — 2019
Press Releases

MCRA Hires FDA Interventional Cardiology Devices Branch Chief Michael John as VP of Cardiovascular Regulatory Affairs

read article
Mar — 2019
Case Studies

Recent MCRA Spine PMA Case Study Success

read article
Jul — 2018
Brochures

Clinical Research Organization

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Jul — 2018
Publications

Medical Device Quality: Why Software Is More Challenging Than Hardware

read article
Mar — 2018
Case Studies

MCRA Reimbursement Case Study

read article
Feb — 2018
Publications

The Impact of U.S. Regulation on Medical Device Innovation

read article
Feb — 2018
News

The Impact of U.S. Regulation on Medical Device Innovation

read article
Feb — 2018
Press Releases

MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

read article
Feb — 2018
Press Releases

MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA

read article
Jan — 2018
Press Releases

MCRA Assists SANUWAVE with Successful De Novo Decision: 3rd Wound Care De Novo Since 2010

read article
Jan — 2018
News

Sanuwave Receives FDA De Novo Decision to Immediately Market the Dermapace System for the Treatment of Diabetic Foot Ulcers in the U.S.

read article
Jan — 2018
Press Releases

MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

read article
Dec — 2017
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