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

About Us

MEET OUR STAFF

PRESIDENT AND FOUNDER

H. Semih Oktay, PhD

VICE PRESIDENT, ENGINEERING

Daniel J. Chwirut, MS, PE

PRINCIPAL CONSULTANTS

Judith J. Danielson, RN, BSN, MPH

Richard E. Galgon, MD, MS

Elisa D. Harvey, DVM, PhD

AFFILIATE CONSULTANTS

Candace F. Cederman, MS

Mona M. Advani, BS, MS, MBA

Jodell D. Kause, BS, RAC

Qmed Consulting

Steven R. Koepke, PhD

Pauline E. McEwan, PhD

Wenda C. Carlyle, PhD

Anna Christensen

Brenda Seidman, MS, PhD

Monique Y. Wells, VMD, MS

CardioMed Device Consultants is an expanding group of professionals with over 60 years of combined experience working in the field of medical device development, evaluation, and review. All of our principal members are former employees of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). They have had integral roles in the review of medical device marketing applications and regulatory submissions, the development of FDA guidance documents, FDA policies, and both U.S. and international voluntary performance standards. They are dynamic individuals with extensive ties throughout CDRH and the medical device industry. Each individual has his/her own area of device expertise; however, their education, experience, and broad knowledge of FDA’s processes and requirements often prove valuable for manufacturers of medical devices intended for other specialty areas.

In addition, CardioMed Device Consultants has incorporated an expanding group of Affiliate Consultants with extensive experience in regulatory affairs and quality assurance from an industry perspective. This addition gives CardioMed Device Consultants a full spectrum team of professionals fully capable of addressing the multitude of needs of the medical device and related industries.

info@cardiomedllc.com