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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
    • Statistical Analysis for Medical Devices
  • 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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Publications

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
Press Releases

MCRA Assists Active Life Scientific with Clinical Study Execution and Successful De Novo Decision for the OsteoProbe - A New Tool to Measure Bone Tissue

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Jan — 2022
Press Releases

MCRA Assists Multiple Clients with Successfully Obtaining CPT Codes and Hospital Payment Reassignments

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Jan — 2022
Press Releases

MCRA Neuro CRO Division Strengthened

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Nov — 2021
Press Releases

MCRA Expands International Regulatory Team

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Nov — 2021
Press Releases

MCRA Expands Neurology Division into Medical Robotics, Exoskeletal and Brain Computer Interface Market

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Oct — 2021
Press Releases

MCRA Expands Neurology Division into Neurointerventional Market

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Sep — 2021
Press Releases

MCRA Expands In-Vitro Diagnostic Device Expertise

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Jul — 2021
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
Webinars

Medical Device Materials: The US and EU Biocompatibility Regulatory Landscape

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Jun — 2021
Webinars

The Path to US Market for Digital Health Technologies

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Jun — 2021
Webinars

Wound Care Innovation: The Call to Clinical Action

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Jun — 2021
Press Releases

MCRA Expands its Cardiovascular Division, Hiring Fernando Aguel, Former Assistant Division Director, FDA Circulatory Support Devices

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May — 2021
Press Releases

MCRA Expands Digital Health Division

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May — 2021
Press Releases

MCRA CRO Assists Simplify Medical, Recently Acquired by NuVasive, on FDA-Approval for Two Level use of its Cervical Disc

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May — 2021
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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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