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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 Publications

Jul — 2024

Oops! A Quick Quip on Device (Mis-)classification

Read Article
Jul — 2024

MCRA Experts Author New Manuscript on Antimicrobial Device FDA Challenges

Read Article
Jul — 2023

Challenges within the European MedTech Market: How MCRA’s Experts Stand Out

Read Article
Jul — 2023

UKCA and CE Transitions for IVD Medical Devices: Planning is Key

Read Article
Feb — 2023

Artificial Intelligence - A Literature Review's Best Frenemy

Read Article
Nov — 2022

Compliance Flash: Holiday Compliance & Privacy

Read Article
Oct — 2022

Compliance Flash: Speaker Program Red Flags

Read Article
Sep — 2022

Compliance Flash: Cyber Criminals Target Healthcare

Read Article
Sep — 2022

MCRA Overview: 2022 FDA Draft Guidance

Read Article
Aug — 2022

Compliance Flash: Sunshine Act and Open Payments

Read Article
Jul — 2022

Compliance Flash: Physician Owned Distributorship

Read Article
Jun — 2022

Compliance Flash: Single Use Devices

Read Article

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The Journey Is Long, Pick The Right Partner

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