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
Press Releases

MCRA Hires Former Leader of FDA Breakthrough Device Program & Neurology Division Manager

Read Press Release
Oct — 2020
Press Releases

MCRA CRO Assists Simplify Medical, Inc. on the Fastest Spine PMA Ever Approved by the FDA

Read Press Release
Oct — 2020
Press Releases

MCRA Expands Neurology Franchise with Hiring of Tim Marjenin, Former FDA Assistant Director

Read Press Release
Aug — 2020
Press Releases

MCRA Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic

read article
Mar — 2020
Press Releases

MCRA Strengthens Its Reimbursement, Health Economics, and Market Access Division with the Hiring of John D. McDermott, Jr., MBA

read article
Jan — 2020
Press Releases

MCRA Assists CorFlow in Obtaining Breakthrough Device Designation

read article
Nov — 2019
Press Releases

THINK Surgical and MCRA Announce 510(k) Clearance and US Launch of Revolutionary Total Knee Replacement Technology

read article
Nov — 2019
Press Releases

MCRA Strengthens its Cardiovascular and Digital Health Franchise with Hiring Former FDA Assistant Director Nicole Goodsell Batista

read article
Nov — 2019
Press Releases

MCRA Assists Intellirod Spine with 1st ever Spine De Novo Decision by the FDA

read article
Apr — 2019
Press Releases

MCRA Assists with Premarket Approval of the M6-C Artificial Cervical Disc - 1st Spine PMA Approved by the FDA in More than Three Years

read article
Mar — 2019
Press Releases

MCRA Hires FDA Interventional Cardiology Devices Branch Chief Michael John as VP of Cardiovascular Regulatory Affairs

read article
Mar — 2019
Press Releases

MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

read article
Feb — 2018
Press Releases

MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Granted by the FDA

read article
Jan — 2018
Press Releases

MCRA Assists SANUWAVE with Successful De Novo Decision: 3rd Wound Care De Novo Since 2010

read article
Jan — 2018
Press Releases

MCRA Offers Informational Presentation on Medical Device Regulation to the Chinese FDA

read article
Dec — 2017
Press Releases

MCRA Leads Innovation Training with FDA as Part of its Experiential Learning Program (ELP)

read article
Nov — 2017
  • 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