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

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 - Anna Christensen

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

Ms. Christensen works with CardioMed Device Consultants as an affiliate consultant. She is a well-recognized regulatory and quality assurance consultant.

As an affiliate consultant, Anna Christensen brings over twelve years of medical device industry experience to CardioMed Device Consultants. Most recently, Ms. Christensen led a successful regulatory and quality assurance consulting business providing services for manufacturers of vascular stents, orthopedic devices, glucose monitors, and surgical instruments, among others. Her areas of expertise include the preparation of regulatory submissions, regulatory compliance, quality system development and implementation, and internal quality auditing.

Prior to consulting, she served as the head of regulatory affairs (RA) and quality assurance (QA) and as a principal RA/QA consultant for a testing lab and consulting firm, while supporting regulatory projects for its parent company. Additionally, she served several years in the regulatory affairs department of a multinational, cardiovascular device manufacturer.

Ms. Christensen is member of the Regulatory Affairs Professional Society (RAPS) and the American Society of Quality (ASQ).

CONTACT MS. CHRISTENSEN

Office: (410) 674-2060

Fax: (410) 674-2133

Email: info@cardiomedllc.com

info@cardiomedllc.com