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 - Jodell D. Kause, BS, RAC

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. Kause works with CardioMed Device Consultants as an affiliate consultant. She is a well-recognized regulatory affairs and quality assurance expert with over twenty years of professional experience working in the medical device and pharmaceutical industries. Over the years, she has held a number of responsible positions within the medical device industry. More recently, she has worked as an independent regulatory and quality insurance consultant, advising medical device consultants on the requirements of the FDA and ISO. Her assistance with analyzing, designing and implementing quality systems and manufacturing GMP/ISO programs has often led to the ability of the companies to either reintroduce products into the market or to keep products on the market. She has helped companies obtain ISO Certification and CE marking under the European Medical Device Directives.

Ms. Kause earned her bachelor of science degree in biomedical engineering from Rensselaer Polytechnic Institute. She is a member of the Regulatory Affairs Professional Society (RAPS) and the American Society for Quality (ASQ).

CONTACT MS. KAUSE

Office: (410) 674-2060

Fax: (410) 674-2133

Email: info@cardiomedllc.com

info@cardiomedllc.com