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
    • 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
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
    • 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
You are here
  • Home
  • News & Publications

News & Publications

Filter By:

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

Compliance Flash: Speaker Program Red Flags

Read Article
Oct — 2022
Press Releases

MCRA Expands Biostatistics Division with Key Hire of Former FDA Biostatistician

Read Article
Oct — 2022
Webinars

Understanding Patient Access Programs

Read Article
Oct — 2022
Publications

Compliance Flash: Cyber Criminals Target Healthcare

Read Article
Sep — 2022
Publications

MCRA Overview: 2022 FDA Draft Guidance

Read Article
Sep — 2022
News

In-Vitro Diagnostic Study Site Form

Read Article
Sep — 2022
Webinars

Video: Navigating the Global IVD Landscape

Read Article
Aug — 2022
Publications

Compliance Flash: Sunshine Act and Open Payments

Read Article
Aug — 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
Publications

Compliance Flash: Physician Owned Distributorship

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
Publications

Compliance Flash: Single Use Devices

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
  • 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