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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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News & Publications

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Case Studies

Case Study: MCRA Supports Darmiyan with FDA Approval for BrainSee Device

Read Case Study
Mar — 2025
Case Studies

Case Study: MCRA Assists Occlutech through Sunshine Act Compliance and Clinical Monitoring Support

Read Case Study
Mar — 2025
Case Studies

Case Study: MCRA Supports 3D Systems with 510(k) FDA Clearance for VSP PEEK Cranial Implant Device

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Feb — 2025
Case Studies

Case Study: MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System

Read Case Study
Jan — 2025
Case Studies

Case Study: MCRA Supports Onkos Surgical with First FDA De Novo Approval for Antibacterial Coating for Implants

Read Case Study
Jan — 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
Case Studies

Case Study: MCRA Assists Australian Company Epiminder with FDA Breakthrough Designation for Epilepsy Monitoring Technology

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Mar — 2024
Case Studies

Case Study: MCRA Assists Australian Company Epiminder with FDA Breakthrough Designation for Epilepsy Monitoring Technology

Read Case Study
Mar — 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

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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
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