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

5523 Research Park Drive, Suite 205, Baltimore, MD   410.674.2060

CardioMed Device Consultants, LLC

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 Welcome to CardioMed Device Consultants online.



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, engineering, and clinical 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.

March 2, 2013 - CardioMed Device Consultants expands its services to include Clinical Trial Services with the addition of Dr. Victor Novack, MD, PhD, and Ms. Jessica Boyle [click here for more info]

May 24, 2012 - Dr. Oktay chaired "Product Development and Regulatory Processes for Medical Devices in Europe and USA" at the MEDTEC UK.  [click here for more info]

May 23, 2012 - Mona Advani presented "FDA Approval Process for Medical Devices - Regulatory and Clinical Considerations" at the Medical Design and Manufacturing (MD&M) East Conference.  [click here for more info]

April 1, 2012 - CardioMed Device Consultants announces Dr. Oktay will chair the inaugural MEDTEC Turkey conference, October 4th, in Istanbul, Turkey, during which Dr. Oktay will also present a master class on the FDA approval process for medical devices.  [click here for more info]

February 7, 2012 - Dr. Oktay presented "Preclinical and Manufacturing: The Real Differences Between US and OUS" at Cardiovascular Research Technologies (CRT) 2012. [click here for more info]

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