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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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  • Publications

MCRA Publications

Jan — 2022

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

Read Article
Jun — 2019

MedTech Strategist - Hot Topics in Cardiovascular Devices with Michael John

read article
May — 2019

The Role of New Technology in Chronic Pain Management

read article
Mar — 2018

Medical Device Quality: Why Software Is More Challenging Than Hardware

read article
Feb — 2018

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

read article
May — 2017

Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

read article
Aug — 2016

Four Questions to Help You Avoid Losing a CE Mark

read article

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The Journey Is Long, Pick The Right Partner

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