CardioMed Device Consultants

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

5523 Research Park Drive, Suite 360, Baltimore, MD 410.674.2060

CardioMed Device Consultants, LLC

In the News

NEWS ARCHIVES

Baltimore, MD, April 1, 2011 - Dr. Oktay proudly announces the addition of Stephen L. Hilbert, PhD, MD, and Sherry Sparrow to the CardioMed team. Dr. Hilbert brings more than thirty years of experience working in the area of cardiovascular medical device development and evaluation, conducting safety and performance and explant pathology studies. His extensive scientific expertise enables him to assist clients at every step of the device development process from early animal testing to clinical trial planning to after-market analysis and regulatory submissions. With his continued research laboratory affiliation, he is capable of offering clients cardiovascular device explant pathology studies, compliant with FDA's Good Laboratory Practices (GLPs). Click [here] for more information regarding Dr. Hilbert's background and expertise. With similar poise, Ms. Sparrow brings over twenty years of experience working as a regulatory affairs professional. She has successfully obtained FDA approval/clearance for a variety of regulatory submission types, including premarket notification [510(k)], investigational device exemption (IDE), and premarket approval (PMA) applications and associated supplements. Click [here] for more information regarding Ms. Sparrow's background and expertise.

Atlanta, GA, March 30, 2011 - Dr. Oktay participated today in a panel discussion titled "Challenges with Medical Device Development: From Benchtop Testing to Clinical Trials" at the Southeastern Medical Device Association's 2011 Conference.

Stuttgart, Germany, March 24, 2011 - Today, Dr. Oktay co-chaired Session 301 - Product Development and FDA Approval Process for Medical Devices at the MEDTEC Europe Conference 2011. This session provided an understanding of the total product life cycle for medical devices, including the challenges associated with research and development, FDA's approval process, and clinical trial considerations.

Anaheim, CA, February 8, 2011 - Today, Dr. Oktay co-chaired Session 202: Product Development and FDA Approval Process for Medical Devices at MD&M West. This session provided an overview and covered key concepts in bringing an innovative medical device to the market, including the product development process, intellectual property considerations, FDA's approval processes, and clinical trial considerations.

Baltimore, MD, January 1, 2011 - CardioMed Device Consultants proudly announces the publication of Dr. Harvey's article titled "HUDs and HDEs: Common Misconceptions and Current Challenges." It appears in the January issue of the Regulatory Focus. It provides helpful information on Humanitarian Use Devices and Humanitarian Device Exemptions. Click here for a copy of the article.

CardioMed Device Consultants has grown over time. Click on a year of interest below to read selected archived press releases.

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