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 - Candace F. Cederman, MS

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. Cederman is a recognized Regulatory Affairs and Quality Assurance expert with over 20 years of professional experience in the medical device field. She has experience as an FDA/CDRH engineer, an FDA field investigator, a manager within the medical device industry, and as an independent regulatory consultant. She is an expert at presenting complicated technical material in an understandable manner.

Ms. Cederman has successfully obtained marketing clearance for a variety of medical devices, both in the United States and internationally. She has also analyzed, designed and implemented GMP/ISO programs for companies with varied regulatory compliance needs. She has been responsible for the conduct and management of FDA inspections including those for GMP and product recalls. She has also helped companies obtain ISO Certification and CE markings under the European Medical Device Directives.

Ms. Cederman received her BS degree in Mechanical Engineering from the University of Maryland, and her MS degree in Engineering Mechanics from Virginia Polytechnic Institute and State University. Ms. Cederman works with CardioMed Device Consultants as an Affiliate Consultant.

CONTACT MS. CEDERMAN

Office: (410) 674-2060

Fax: (410) 674-2133

Email: info@cardiomedllc.com

info@cardiomedllc.com