Ann Marie Gaitan offers FREE webinar on medical device regulation

Due to the overwhelming positive response after Mrs. Gaitan’s speaking engagement at the FIME International Medical Exposition on “How FDA Regulates Non-Compliant Medical Devices Not Intended for U.S. Consumers”, Mrs. Gaitan will be presenting a webinar on basic FDA requirements for medical devices on Monday, September 30^th, 2013.

“Introduction to FDA Medical Device Regulatory Requirements” will provide an overview of FDA’s requirements and expectations affecting entities involved in the manufacturing and/or distribution of medical devices in the U.S., while offering practical business strategies for continued compliance.  Issues covered include, determining medical device classification, 510(k) clearances and pre-market approvals (PMA), medical device establishment registration requirements as amended by MDUFA (2012) and medical device product listing requirements.

To learn more or interested in registering for this FREE webinar click here.