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

Affiliate Consultant - Brenda Seidman, MS, PhD

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

Dr. Seidman is a recognized biocompatibility expert and respected toxicologist/pharmacologist with over 20 years experience in medical device and drug/device combination product consulting, including a great deal of experience in developing and placing analytical chemistry studies for evaluations of device extractables and leachables. In addition, she holds considerable knowledge and reguatory expertise gained as scientific reviewer in the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research. (CDER).

Dr. Seidman earned her MS and PhD degrees in toxicology from the University of California, Los Angeles. She performed postdoctoral research at the Unversity of California, San Francisco, on Scrapie, a neurological disease of sheep related to other spongiform encephalopathies, such as “Mad Cow” disease. In 1987, she began her career as a toxicology consultant, first focusing on environmental pollutants and pesticides, and then medical device biocompatibility, toxicology, and risk assessment. She has worked with many large and small medical device manufacturers in the development, placement, and management of a wide variety of nonclinical and analytical studies, both for qualification testing and trouble shooting purposes. In doing so, she has provided critical review and interpretation of study data, and has prepared numerous regulatory submissions to FDA.

In July 2005, Dr. Seidman joined FDA/CDER as a scientific reviewer. During her tenure, she reviewed anti-obesity, diabetes, lipid-lowering, and biologic oncology therapeutics. She organized and lectured in an Agency-wide Good Laboratory Practice (GLP) course. In January 2008, she returned to consulting, while participating as well as a Fellow in CDER’s Division of Cardiovascular and Renal Products' QTc prolongation project (through February 2009).

With her strong technical background, analytical skills, and understanding of the medical device industry and the regulatory challenges, Dr. Seidman can provide expert assistance in product development, overall study program planning and management, gap analysis, and testing strategies.

CONTACT DR. SEIDMAN

Office: (410) 674-2060

Fax: (410) 674-2133

Email: info@cardiomedllc.com

info@cardiomedllc.com