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

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Gambrills, MD, January 2, 2003 - Semih Oktay and Dan Chwirut proudly announce the formation of CardioMed Device Consultants. CardioMed Device Consultants provides regulatory and engineering consulting services to the medical device industry, focusing primarily on the device development and validation process and regulatory approval strategy.

Dr. Oktay and Mr. Chwirut were previously employed as scientific reviewers for medical devices at the U.S. Food and Drug Administration, and most recently as consultants for MicroMed Laboratories, Inc. Although they specialized in cardiovascular devices at the FDA, their previous education, experience and broad knowledge of FDA's process and requirements provide a valuable resource for numerous medical specialty areas.

Dr. Oktay received his PhD, in the field of biomechanics, from the University of Maryland Baltimore County, with a research focus on the effects of angioplasty on arterial wall mechanics. At the FDA, he was the lead scientific reviewer for coronary stents in the Division of Cardiovascular Devices, Office of Device Evaluation.

Mr. Chwirut received his MS from the University of Maryland College Park in the field of solid mechanics and is a registered professional engineer in the State of Maryland. Prior to leaving FDA, he was the senior mechanical engineer in the Division of Mechanics & Materials Science, consulting on pre- and post-approval issues on implant devices and developing performance standards for those devices.

Both Dr. Oktay and Mr. Chwirut have assumed key leadership roles in ASTM and ISO consensus standards activities.

Based on their experience at the FDA and as consultants at MicroMed, the principals at CardioMed have strong ties within the FDA, the medical device industry, device testing and analysis labs, quality consulting firms, and other engineering and regulatory specialists, and have formal and informal referral arrangements with numerous resources.

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]

info@cardiomedllc.com