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

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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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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Aug — 2016

Four Questions to Help You Avoid Losing a CE Mark

A Clinical Evaluation Report (CER) is part of the process through which a medical device is certified or recertified to carry the CE mark; it appli

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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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