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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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Webinars

Navigating MDR expectations for tomorrow based on Notified Body feedback today

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Jun — 2021
Webinars

Medical Device Materials: The US and EU Biocompatibility Regulatory Landscape

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Jun — 2021
Webinars

The Path to US Market for Digital Health Technologies

Read Article
Jun — 2021
Webinars

Wound Care Innovation: The Call to Clinical Action

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Jun — 2021
Press Releases

MCRA Expands its Cardiovascular Division, Hiring Fernando Aguel, Former Assistant Division Director, FDA Circulatory Support Devices

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May — 2021
Press Releases

MCRA Expands Digital Health Division

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May — 2021
Press Releases

MCRA CRO Assists Simplify Medical, Recently Acquired by NuVasive, on FDA-Approval for Two Level use of its Cervical Disc

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May — 2021
Press Releases

MCRA Hires Former Leader of FDA Breakthrough Device Program & Neurology Division Manager

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Oct — 2020
Press Releases

MCRA CRO Assists Simplify Medical, Inc. on the Fastest Spine PMA Ever Approved by the FDA

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Oct — 2020
Press Releases

MCRA Expands Neurology Franchise with Hiring of Tim Marjenin, Former FDA Assistant Director

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Aug — 2020
Press Releases

MCRA Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic

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Mar — 2020
Press Releases

MCRA Strengthens Its Reimbursement, Health Economics, and Market Access Division with the Hiring of John D. McDermott, Jr., MBA

read article
Jan — 2020
Press Releases

MCRA Assists CorFlow in Obtaining Breakthrough Device Designation

read article
Nov — 2019
Press Releases

THINK Surgical and MCRA Announce 510(k) Clearance and US Launch of Revolutionary Total Knee Replacement Technology

read article
Nov — 2019
Press Releases

MCRA Strengthens its Cardiovascular and Digital Health Franchise with Hiring Former FDA Assistant Director Nicole Goodsell Batista

read article
Nov — 2019
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