Skip to main content
Top Menu
  • ABOUT US
    • About Us
    • Careers
    • Meet Our Team
  • NEWS & PUBLICATIONS
    • News
    • Publications
Home
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
Contact Us
Contact Us
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
You are here
  • Home
  • News & Publications

News & Publications

  • Press Releases
  • Case Studies
  • Publications
  • Webinars
  • News
  • Brochures
News

In-Vitro Diagnostic Study Site Form

Read Article
Sep — 2022
Press Releases

MCRA Expands Recently Formed Biocompatibility Division with 2 Key Hires from FDA and Industry

Read Article
Aug — 2022
Press Releases

MCRA Assists NeuroMetrix with Obtaining FDA Breakthrough Device Designation and Marketing Authorization in One Year

Read Article
Jul — 2022
Press Releases

MCRA and Clients Achieve Significant Milestone - Over 60 Breakthrough Device Designations Granted by FDA

Read Article
Jun — 2022
Press Releases

MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA

Read Article
Jun — 2022
Press Releases

MCRA Assists Net Health in Receiving Breakthrough Device Status

Read Article
Jun — 2022
Press Releases

MCRA Acquires Vorpal Technologies K.K. to Further Expand its Global Advisory Services in Japan

Read Article
Mar — 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

Read Article
Jan — 2022
Press Releases

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

Read Article
Jan — 2022
Press Releases

MCRA Neuro CRO Division Strengthened

Read Article
Nov — 2021
Press Releases

MCRA Expands International Regulatory Team

Read Article
Nov — 2021
Press Releases

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

Read Article
Oct — 2021
Press Releases

MCRA Expands Neurology Division into Neurointerventional Market

Read Article
Sep — 2021
Press Releases

MCRA Expands In-Vitro Diagnostic Device Expertise

Read Article
Jul — 2021
Press Releases

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

Read Article
May — 2021
Press Releases

MCRA Expands Digital Health Division

Read Article
May — 2021
  • LOAD MORE
The Journey Is Long, Pick The Right Partner

MCRA's world class know-how and execution unlocks barriers, advancing our clients mission to better the availability of quality medical care to patients around the world.

Learn More

An IQVIA Business

MCRA/IQVIA logo

Contact Us

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.

Footer Navigation
  • About Us
  • Services
  • Therapy Specialization
  • Geographies
  • News & Publications
  • Careers
  • Contact Us

Subscribe to our newsletter.

  • © 2025

    All Rights Reserved | Privacy Policy | Your Privacy Choices privacy options