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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

Medical Device Quality: Why Software Is More Challenging Than Hardware

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Mar — 2018
Case Studies

MCRA Reimbursement Case Study

read article
Feb — 2018
Publications

The Impact of U.S. Regulation on Medical Device Innovation

read article
Feb — 2018
News

The Impact of U.S. Regulation on Medical Device Innovation

read article
Feb — 2018
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
News

Sanuwave Receives FDA De Novo Decision to Immediately Market the Dermapace System for the Treatment of Diabetic Foot Ulcers in the U.S.

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
Press Releases

FDA Selects MCRA to Share Expertise as Part of the Experiential Learning Program (ELP)

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Sep — 2017
Press Releases

MCRA Releases New White Paper Analyzing the Industry Impact of the Federal Budget Request on FDA

read article
Jul — 2017
Press Releases

MCRA Advises Orthopedic Industry To Adopt Integrated Value Creation Strategy

read article
Jul — 2017
Publications

Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

read article
May — 2017
News

Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

read article
May — 2017
Press Releases

MCRA Expands, Moves to New DC Location

read article
Feb — 2017
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