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  • 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

Mastering Healthcare Transactions: A Strategic Approach to Compliance, Safe Harbors, and Regulatory Challenges - MCRA Webinar

Watch Mastering Healthcare Transactions Now.
May — 2025
Webinars

FDA Layoffs and the Impact to Industry - MCRA Webinar

Watch Webinar
Mar — 2025
Webinars

Category III CPT Codes: Challenges and Opportunities - MCRA Webinar

Watch Webinar
Sep — 2024
Webinars

LDT vs IVD: Adapting to the New FDA Regulations - MCRA Webinar

Watch Webinar
Jul — 2024
Webinars

Reimbursement Considerations in Product Commercialization Webinar

Watch Webinar
Jun — 2024
Webinars

Transition from EFS to Pivotal for Implanted BCI Devices: Patient, Regulatory, and Reimbursement Perspectives Webinar

Watch Webinar
May — 2024
Webinars

FDA Cybersecurity and Software Policy Updates: Navigating the New FDA Guidance Documents for MedTech Webinar

Watch Webinar
Sep — 2023
Webinars

Navigating the Road to Successful Market Access: Health Economic Strategies for Medtech Innovators

Read Article
May — 2023
Webinars

Understanding Patient Access Programs

Read Article
Oct — 2022
Webinars

Video: Navigating the Global IVD Landscape

Read Article
Aug — 2022
Webinars

Considerations for Orthopedic Implant Associated Antimicrobial Agents: Regulatory Science

Read Article
Jun — 2021
Webinars

Navigating MDR expectations for tomorrow based on Notified Body feedback today

Read Article
Jun — 2021
Webinars

Medical Device Materials: The US and EU Biocompatibility Regulatory Landscape

Read Article
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

Read Article
Jun — 2021
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