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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
    • AI & Imaging Center
    • Statistical Analysis for Medical Devices
    • Biocompatibility Services
    • Cybersecurity Solutions
    • Global Regulatory
    • Europe Regulatory
    • Japan Clinical and Regulatory
    • Quality Assurance
    • Healthcare Compliance
    • Talent 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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Understanding Patient Access Programs

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Oct — 2022
Publications

Compliance Flash: Cyber Criminals Target Healthcare

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Sep — 2022
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MCRA Overview: 2022 FDA Draft Guidance

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Sep — 2022
Webinars

Video: Navigating the Global IVD Landscape

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Aug — 2022
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Compliance Flash: Sunshine Act and Open Payments

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Aug — 2022
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Compliance Flash: Physician Owned Distributorship

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Jul — 2022
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Compliance Flash: Single Use Devices

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Jun — 2022
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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
Webinars

Considerations for Orthopedic Implant Associated Antimicrobial Agents: Regulatory Science

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Jun — 2021
Webinars

Navigating MDR expectations for tomorrow based on Notified Body feedback today

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Jun — 2021
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Medical Device Materials: The US and EU Biocompatibility Regulatory Landscape

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Jun — 2021
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The Path to US Market for Digital Health Technologies

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Jun — 2021
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Wound Care Innovation: The Call to Clinical Action

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Jun — 2021
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MedTech Strategist - Hot Topics in Cardiovascular Devices with Michael John

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Jun — 2019
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The Role of New Technology in Chronic Pain Management

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May — 2019
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Medical Device Quality: Why Software Is More Challenging Than Hardware

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Mar — 2018
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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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