CardioMed Device Consultants - Vice President, Daniel J. Chwirut, MS, PE

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

Affiliate Consultant - Mona M. Advani, MS, MBA

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

Ms. Advani is a recognized consultant with over ten years of professional experience in domestic and international regulatory affairs. She has worked with small and large medical device companies, developing regulatory and clinical strategies and preparing clinical reports and premarket submissions for medical device products.

Ms. Advani has successfully obtained marketing clearance for a variety of medical devices, both in the United States and internationally, including the European Union (EU), Japan and Canada. She has successfully prepared clients for and represented clients in regulatory meetings with FDA, including FDA panel meetings. She has worked in the medical device industry holding the titles of Director of Regulatory Affairs and Clinical Research, Manager of Business Development, Manager of U.S. Regulatory Affairs, Manager of International Regulatory Affairs, and Regulatory Affairs Coordinator. In addition, she is fluent in written and spoken Japenese.

Ms. Advani earned her MBA degree from San Francisco State University, her MS degree in Immunology of Infectious Disease from the University of London, and her BS degree in Biology from Brown University. She has organized international regulatory affairs workshops; presented at the RAPS Annual Regulatory Affairs Professionals Society Meeting; and published articles in the Regulatory Affairs Focus magazine. Ms. Advani works with CardioMed Device Consultants as an Affiliate Consultant.

CONTACT MS. ADVANI

Office: (410) 674-2060

Fax: (410) 674-2133

Email: info@cardiomedllc.com

info@cardiomedllc.com