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

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 Site Map

About Us - An overview of CardioMed Device Consultants

President and Founder - H. Semih Oktay, PhD
Honorary VP (Retired) - Daniel J. Chwirut, MS, PE
Principal Consultants - Judith J. Danielson, RN, BSN, MPH, Richard E. Galgon, MD, MS, Elisa D. Harvey, DVM, PhD, and Stephen L. Hilbert, PhD, MD
Affiliate Consultants - Candice F. Cederman, MS, Mona M. Advani, MS, MBA, RAC, Jodell D. Kause, BS, RAC, Qmed Consulting, Steven R. Koepke, PhD, Pauline E. McEwan, PhD, Wenda C. Carlyle, PhD, Anna Christensen, and Monique Y. Wells, VMD, MS, Sherry L. Sparrow, BA

Services - An overview of services provided by CardioMed Device Consultants

Regulatory Consulting Services
Engineering Consulting Services
Regulatory Training Services
Quality Assurance Consulting Services

News - Articles and press releases regarding CardioMed Device Consultants and its members

Publications - Pertinent scientific and technical publications by members of CardioMed Device Consultants

Useful Links - External Links to useful web sites

U.S. Government

• U.S. Food and Drug Administration (FDA)
• Center for Devices and Radiological Health (CDRH)
• Office of Device Evaluation (ODE)
• Office of Combination Products
• Office of Orphan Products Development
• CDRH Databases
• CDRH Device Advice

• Medical and Professional Societies

• American College of Cardiology
• The Society for Cardiac Angiography and Interventions
• American Heart Association
• The American Society of Mechanical Engineers

• Standards Development Organizations

• Association for the Advancement of Medical Instrumentation (AAMI)
• American National Standards Institute (ANSI)
• American Society for Testing and Materials (ASTM)
• International Electrotechnical Committee (IEC)
• International Organization for Standardization
• NCCLS

Contact Us - A listing of CardioMed Device Consultants contact information

• Mailing Address
• Phone
• Fax
• Email
• Office Manager

Find Us - Driving directions to our office

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