News & Publications

Press Releases

Nov — 2019

MCRA Assists CorFlow in Obtaining Breakthrough Device Designation

MCRA, LLC, a leading medical device advisory firm and Clinical Research Organization (CRO

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Nov — 2019

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

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Nov — 2019

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

WASHINGTON DC, November 19, 2019 /PRNewswire/ -- MCRA, LLC, is a leading medical device advisory firm and clinical research organization (CRO) that

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Aug — 2019

MCRA Hires Reimbursement Leader Tonya N. Dowd, MPH, as Vice President of Reimbursement, Health Economics, & Market Access

WASHINGTON, AUG 22, 2019 /CMW/ -- MCRA, LLC a leading medical device advisory firm and Clinical Research Organization (CRO) integrating US and Int

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MCRA in the News

Feb — 2018

New York Times FDA Panel Supports Artificial Disks for Upper Spine

GAITHERSBURG, Md., Sept.

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Feb — 2018

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

Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators.

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Jan — 2018

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

SUWANEE, GA, Jan. 02, 2018 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB: SNWV) has announced that the U.S.

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May — 2017

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

For a company navigating a Class III medical device’s path to market, the U.S.

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MCRA Publications

Jun — 2019

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

Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators.

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Recent Webinars

Jun — 2018

Successfully Integrating Your Reimbursement & Product Development Strategy

Many medical device companies develop a coverage and reimbursement strategy as a standalone model.

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Jun — 2018

Knowledge is Power: The Most Common Causes of 483s

This presentation will discuss common 483s, and how to prevent them, including:

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Case Studies

Jul — 2018

Recent MCRA Spine PMA Case Study Success

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Feb — 2018

MCRA Reimbursement Case Study

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Brochures

Jul — 2018

Clinical Research Organization

Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) provides a fully integrated Clinical Research Organization (CRO) that creates value by col

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News & Publications

Press Releases

MCRA Assists CorFlow in Obtaining Breakthrough Device Designation

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

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

MCRA Hires Reimbursement Leader Tonya N. Dowd, MPH, as Vice President of Reimbursement, Health Economics, & Market Access

MCRA in the News

New York Times FDA Panel Supports Artificial Disks for Upper Spine

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

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

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

MCRA Publications

MedTech Strategist - Hot Topics in Cardiovascular Devices with Michael John

The Role of New Technology in Chronic Pain Management

Medical Device Quality: Why Software Is More Challenging Than Hardware

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

Recent Webinars

Successfully Integrating Your Reimbursement & Product Development Strategy

Knowledge is Power: The Most Common Causes of 483s

Case Studies

Recent MCRA Spine PMA Case Study Success

MCRA Reimbursement Case Study

Brochures

Clinical Research Organization