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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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Webinars

FDA Layoffs and the Impact to Industry - MCRA Webinar

Watch Webinar
Mar — 2025
Case Studies

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
Publications

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

Read Article
Jul — 2024
Webinars

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

Watch Webinar
Jul — 2024
Publications

MCRA Experts Author New Manuscript on Antimicrobial Device FDA Challenges

Read Article
Jul — 2024
Press Releases

MCRA Supports CamDiab with FDA Approval for Artificial Pancreas Software

Read Press Release
Jun — 2024
Press Releases

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

Read Press Release
Jun — 2024
Press Releases

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

Read Press Release
Jun — 2024
Webinars

Reimbursement Considerations in Product Commercialization Webinar

Watch Webinar
Jun — 2024
Press Releases

MCRA Announces Record Success in Supporting Orthopedic Innovation

Read Press Release
May — 2024
Press Releases

MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with OstaguardTM Coating

Read Press Release
May — 2024
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