CardioMed Device Consultants

A medical device consulting company working with medical device manufacturers around the world

1327 Bluegrass Way, Gambrills, MD 21054 410.674.2060

CardioMed Device Consultants, LLC

In the News

NEWS ARCHIVES

April 30, 2008 - CardioMed Device Consultants proudly announces the publication of Dr. Harvey's article titled "Resolving Disputes with Your US FDA Review Team." It appears in the May issue of the Journal of Medical Device Regulation. It provides helpful information on how to go about solving the problem of a difference of opinion with an FDA review team." Click here for a copy of the article.

Gambrills, MD, March 1, 2008 - CardioMed Device Consultants proudly welcomes the addition of Dr. Pauline McEwan to its expanding team of Affiliate Consultants. Dr. McEwan is a well-recognized consultant in the area of cardiovascular medicine and combination products. She adds expertise regarding drug-related issues associated with drug-eluting stents.

Gambrills, MD, November 15, 2007 - CardioMed Device Consultants proudly announces the addition of Dr. Steven Koepke and Qmed Consulting to its team of Affiliate Consultants. Dr. Koepke brings a wealth of knowledge regarding combination products with emphasis on drug-eluting stents. Qmed Consultants provides expertise and knowledge for clients seeking guidance on European Union (EU) requirements.

Gambrills, MD, November 1, 2007 - CardioMed Device Consultants proudly announces the publication of Dr. Harvey's article titled "You Have Met with the US FDA - Now What?." It appears in the November issue of the Journal of Medical Device Regulation. It focuses on the various things that can or should occur during and especially following a meeting with the FDA and how to react to ensure the project continues to move forward. Click here for a copy of the article.

Gambrills, MD, May 1, 2007 - CardioMed Device Consultants proudly announces the publication of Dr. Harvey's article titled "Successfully Interacting with the US FDA." It appears in the May issue of the Journal of Medical Device Regulation. It focuses on how sponsors can improve and optimize their interactions with the US Food and Drug Administration (FDA) when attempting to bring a new medical device into the US marketplace. Click here for a copy of the article.

Gambrills, MD, April 15, 2007 - CardioMed Device Consultants proudly announces that Dr. Oktay and Mr. Chwirut will continue their involvement in the development of voluntary performance standards by once again participating in the spring meeting of the ASTM Endovascular Devices Test Methods Task Group. In 2003, Mr. Chwirut was awarded the Award of Merit by ASTM International and the accompanying title of Fellow, the highest society recognition for individual contributions to standards activities. Through his work, voluntary standards, rather than federal regulation, have been emphasized, and these voluntary standards have been widely circulated throughout the industry.

Dr. Harvey joins CardioMed Device Consultants. [Go to story]

Mr. Chwirut receives the ASTM International's Award of Merit and the accompanying title of Fellow. [Go to story]

Dr. Galgon joins CardioMed Device Consultants. [Go to story]

Ms. Danielson joins CardioMed Device Consultants. [Go to story]

Semih Oktay and Dan Chwirut announce the formation of CardioMed Device Consultants. [Go to story]

info@cardiomedllc.com