News & Publications

Press Releases

Apr — 2019

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

WASHINGTON, April 4, 2019 /PRNewswire/ -- MCRA, LLC has announced its role in the successful granting of the first De Novo for a device in

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Mar — 2019

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

WASHINGTON, March 7, 2019 /PRNewswire/ -- MCRA, LLC announced today its role in the successful Premarket Approval (PMA) application decision by th

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Mar — 2019

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

WASHINGTON, March 5, 2019 /PRNewswire/ -- MCRA, LLC, a leading medical device consulting firm and clinical research organization (CRO) that integra

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Feb — 2018

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

The session aimed to collaboratively explore U.S. device regulations and offer high-level knowledge about the FDA review process.

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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

MedTech Strategist - Hot Topics in Cardiovascular Devices with Michael John

Executive Interview

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May — 2019

The Role of New Technology in Chronic Pain Management

MCRA Whitepaper Apri

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Mar — 2018

Medical Device Quality: Why Software Is More Challenging Than Hardware

The U.S.

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

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

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

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

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

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