CardioMed Device Consultants

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

5523 Research Park Drive, Suite 110, Baltimore, MD 410.674.2060

CardioMed Device Consultants, LLC

In the News

NEWS ARCHIVES

San Francisco, CA, September 21-25, 2009 - During this 5-day period, Dr. Oktay participated as a faculty member at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference. He presented "Basics of Submission: 510(k), IDE, and IND" and "Bench Testing for Cardiovascular Devices: General Principles" during the Comprehensive Training In Clinical Research course. In addition, he participated as a panelist at the FDA Town Hall Meeting and presented "Assessing Nitinol Stent Structural Integrity (FEA and Durability Bench Testing) and Preparation of a Suitable FDA Pre-Clinical Dossier" at the session titled "The Re-Emergence of Nitinol Self-Expanding Coronary Stents."

Baltimore, MD, August 1, 2009 - CardioMed announces its move to a new office located in the UMBC Research and Technology Park. The new location is only minutes away from BWI Thurgood Marshall Airport, downtown Baltimore, and the federal agencies located in the Washington, DC corridor, including the US Food and Drug Administration. Click here for more information and driving directions to the new location.

Gambrills, MD, July 20, 2009 - CardioMed announces the co-publication of "Fatigue to Fracture: An Informative, Fast, and Reliable Approach for Assessing Medical Implant Durability" by Mr. Chwirut in the Journal of ASTM International. The paper compares the differences between the "test to success" and "test to fracture" paradigms for medical implant durability assessment. Click here to view this article.

Gambrills, MD, March 1, 2009 - CardioMed Device Consultants proudly announces the addition of Dr. Brenda Seidman to its team of Affiliate Consultants. Dr. Seidman adds over 20 years of medical device and drug/device combination product consulting experience, as well as experience as a reviewer in FDA's Center for Drug Evaluation and Research. Click here to learn more about Dr. Seidman's experience.

Silver Spring, MD, December 9, 2008 - Dr. Harvey participated today, as an invited guest speaker, in the FDA/AdvaMed workshop titled "Gender Differences in Cardiovascular Device Trials." She co-presented a talk titled "A Regulatory Perspective on Women in Clinical Trials." This session presented an historical perspective regarding the inclusion of women in clinical trials; discussed valid reasons for excluding women in trials; discussed challenges in recruitment and retention of women in trials; discussed NHLBI/NIH requirements and experiences in the recruitment and retention of women in trials; and presented lessons learned from the Women's Health Initiative.

Gambrills, MD, December 7, 2008 - CardioMed Device Consultants proudly announces the addition of Anna Christensen to its team of Affiliate Consultants. Ms. Christensen is well versed in regulatory affairs and quality assurance issues and programs and brings a great deal of industry perspective to CardioMed. Click here to learn more about Ms. Christensen's experience.

Gambrills, MD, July 21, 2008 - CardioMed Device Consultants published an article titled "How to Submit Preclinical Data to ODE" in Medical Device & Diagnostic Industry. This article provides key points for avoiding costly mistakes for companies planning and preparing to submit preclinical testing information to FDA. Click here to view this article.

Gambrills, MD, July 18, 2008 - CardioMed Device Consultants proudly announces the addition of Dr. Wenda C. Carlyle to its team of Affiliate Consultants. Dr. Carlyle adds a great deal of knowledge and experience in basic biology, pharmacology, medical device development, and the medical device business. She is a well-recognized consultant in the area of cardiovascular biology and combination products. Click here to learn more about Dr. Carlyle's experience.

Gambrills, MD, 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. Click here to learn more about Dr. McEwan's experience.

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. Click here to learn more about Dr. Koepke or here for information about Qmed Consultants.

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.

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