News & Publications

Press Releases

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.

read article

Jan — 2018

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

WASHINGTON, Jan.

read article

Jan — 2018

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

SANUWAVE retained MCRA in January of 2015 to lead interactions and correspondence with the FDA for the dermaPACE.

read article

Dec — 2017

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

NEW YORK, Dec.

read article

MCRA in the News

Feb — 2018

New York Times FDA Panel Supports Artificial Disks for Upper Spine

GAITHERSBURG, Md., Sept.

read article

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.

read article

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.

read article

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.

read article

MCRA Publications

Mar — 2018

Medical Device Quality: Why Software Is More Challenging Than Hardware

The U.S.

read article

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.

read article

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.

read article

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

read article

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.

read article

Jun — 2018

Knowledge is Power: The Most Common Causes of 483s

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

read article

Case Studies

Jul — 2018

Recent MCRA Spine PMA Case Study Success

spine%20pma.JPG

read article

Feb — 2018

MCRA Reimbursement Case Study

reimbursement%20case.JPG

read article

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

read article