With the gradual elimination of economic boundaries, more and more U.S. manufacturers will need the “CE” mark on their products in order to market them in Europe.  The CE mark indicates that the product meets the European Union’s standards for consumer safety.  These resources contain information on the CE mark, including what it is, how to get it, and how to keep it.

Deborah Ford is a QPharma Regional Manager, located in Bethesda, MD., and responsible for the Midatlantic region.  Deborah has over 20 years experience working in quality in both regulated and non-regulated organizations.  She has led numerous projects to put in quality systems in compliance with the Quality System Regulation, ISO 13485, ISO 9001, IVDD, MDD, and CMDR.  The quality systems for IVDD and MDD required her to understand and implement products that required the CE mark.

Jeff Boatman is a Subject Matter Expert on Medical Devices and Quality Systems at QPharma headquarters in Morristown, N.J. Jeff has 20 years in the Life Sciences industry as a manufacturing, validation, quality, and R&D engineer.  A Certified Quality Auditor, he holds several Medical Device patents and teaches Quality Systems through the American Society for Quality.  In 1993, Jeff was an R&D Lab Supervisor at Becton Dickinson when EN46001 compliance became a corporate objective, and so was intimately involved with CE marking from the beginning.