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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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  • MCRA In the News

MCRA In the News

Sep — 2023

Update to FDA Guidance Use of International Standard ISO 10993-1 and Biocompatibility of Devices in Contact with Intact Skin

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Sep — 2022

In-Vitro Diagnostic Study Site Form

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Feb — 2018

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

read article
Jan — 2018

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
May — 2017

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

read article
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IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry dedicated to delivering actionable insights. Learn more at www.iqvia.com.

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