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

Welcome to CardioMed Device Consultants online.

IN THE NEWS

Success in the rapidly changing and highly competitive world of medical devices demands people with the right experience and expertise. Errors in device design, test methodology, and regulatory strategy lead to costly delays.

At CardioMed Device Consultants, we are dedicated to working with the medical device and related industries to help bring safe and effective products to the market in a timely and efficient manner. Our professionals have extensive regulatory and engineering experience, as well as ties with the U.S. Food and Drug Administration (FDA), the medical device consulting and testing industry, the medical community, and voluntary standards development organizations.

We are a focus-driven company. We keep our fingers on the pulse of the rapidly changing and increasingly complex medical device regulatory environment, which enables us to serve you better and ensure a rapid, smooth pathway to the market for your product. In short, whether you are a large or small medical device manufacturer, you can count on us to help you achieve your product development and marketing goals.

October 20, 2009 - Dr. Oktay co-chairs the session titled "Product Development Process for Medical Devices" at MD&M's annual Expo and Conference.

September 21-25, 2009 - Dr. Oktay participates as faculty at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference. [click here to read more]

August 1, 2009 - CardioMed moves to a new office location located in the UMBC Research and Technology Park. [click here to read more]

July 20, 2009 - Dan Chwirut co-publishes "Fatigue to Fracture" in the Journal of ASTM International. [click here to preview]

December 9, 2008 - Dr. Harvey participated today, as an invited speaker, in the FDA/AdvaMed workshop titled "Gender Differences in Cardiovascular Device Trials. [click here to read more]

July 21, 2008 - CardioMed consultants publish "How to Submit Preclinical Data to ODE" in Medical Device & Diagnostic Industry (MD&DI). [click here to preview]

April 30, 2008 - Dr. Harvey publishes "Resolving Disputes with Your US FDA Review Team" in the May issue of the Journal of Medical Device Regulation. [click here to preview]

May 1, 2007 - Dr. Harvey publishes article titled "Successfully Interacting with US FDA" in the May issue of the Journal of Medical Device Regulation. [click here to preview]

April 1, 2007 - CardioMed Device Consultants and SPI USA continue their collaboration to provide point-of-fact training seminars on FDA medical device regulations and approval processes.

info@cardiomedllc.com