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 360, Baltimore, MD 410.674.2060

CardioMed Device Consultants, LLC

Affiliate Consultant - Sherry L. Sparrow, BA

MEET OUR STAFF

PRESIDENT AND FOUNDER

H. Semih Oktay, PhD

HONORARY VP, ENGINEERING

Daniel J. Chwirut, MS, PE

PRINCIPAL CONSULTANTS

Judith J. Danielson, RN, BSN, MPH

Richard E. Galgon, MD, MS

Elisa D. Harvey, DVM, PhD

Stephen L. Hilbert, PhD, MD

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

Monique Y. Wells, VMD, MS

Sherry L. Sparrow, BA

Ms. Sparrow is an Affiliate Consultant with over twenty years of experience working as a Regulatory Affairs professional. Prior to working with CardioMed, she worked with major medical device companies involved in the development of in vitro diagnostic, neurological, and coronary and peripheral endovascular products.

Ms. Sparrow has successfully obtained FDA approval/clearance for a variety of regulatory submission types, including premarket notification [510(k)], investigational device exemption (IDE), and premarket approval (PMA) applications and associated supplements. She has extensive experience interacting with the Agency and preparing for FDA meetings. In addition, Ms. Sparrow is a trained technical writer and has conducted workshops on effective writing, formatting, and orgainization for successful regulatory submissions. She has also developed work instructions and templates for FDA submissions.

Ms. Sparrow earned her degree in zoology from the University of Minnesota and holds a California Secondary Teaching Certification in biological science.

CONTACT MS. SPARROW

Office: (410) 674-2060

Fax: (410) 674-2133

Email: info@cardiomedllc.com

info@cardiomedllc.com