AdvaMed Presents CE Marking 101, Sept. 25-26, Washington DC
(EMAILWIRE.COM, September 06, 2002 ) WASHINGTON DC USA -- MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) -- AdvaMed's (formerly HIMA) Medical Technology Learning Institute, in cooperation with Duquesne University & the Intl Trade Administration, announced details today of its upcoming regulatory seminar: CE Marking 101. The Sept. 25-26, 2002 event, to be held in Washington DC, reviews how to obtain a CE Mark for your product.
BACKGROUND:
AdvaMed regulatory officials have a wealth of experience in getting CE marks for their products and interacting with representatives from notified bodies. Attend this 1 1/2-day seminar and find out the do's and don'ts from experienced regulatory professionals, representatives from notified bodies, and government and university officials.
BENEFITS OF ATTENDING THIS SEMINAR:
What you will learn:
-- How to classify your product using Conformity Assessment Procedures
-- How to determine in which category your product belongs
-- Strategies for working with a notified body and surveillance authorities
-- The criteria for selecting among the available options
-- The definition of a medical device
-- The first-hand experiences of companies getting a CE Mark
-- The key provisions of the medical device directives, including the IVD directive
-- The requirements for documentation
-- The role of notified bodies
-- The various conformity assessment options
-- What clinical data is required
-- What to consider when selecting a notified body
-- When a safety analysis is required
-- When clinical evaluations are necessary and what data is required
-- Which directives apply to which of your products
-- Which products don't require a CE mark
EXPERT PANEL OF SPEAKERS:
Hear an expert panel discuss these issues, then collaborate with your industry peers during interactive, problem-solving activities:
-- Frances Akelewicz, Practical Solutions, LLC (formerly with BD)
-- John Beasley, TUV
-- Paul Brooks, BSI
-- Malcolm Carlisle, Consultant to Morgan Lewis
-- Kathryn Gleason, Morgan Lewis
-- David P. Hanson, Center for Intl Trade Regulation Assistance, Duquesne U
-- Gonzalo Manchego, Center for Intl Trade Regulation Assistance, Duquesne U
-- Patricia Murphy, KEMA
-- Christine Nelson, FDA
-- Nancy Singer, AdvaMed
-- Ken Sumner, Ph.D., Weinberg Group (formerly with CR Bard)
-- Anthony Warnock-Smith, Morgan Lewis
-- Klaus-Dieter Willamowski, Roche Diagnostics, Germany
REGISTRATION INFORMATION:
Registration Fee is $895 for members, $1,530 for nonmembers. Payment should be made online, by credit card only (American Express, Master Card, or VISA).
http://mailiwant.com/links.jsp?linkid=2001&;subid=625344&campid=6380
PREREGISTRATION IS REQUIRED - SEATING IS LIMITED:
Attendance is limited and pre-registration is required. No walk-ins will be accepted. Register today. We have had to turn people away from most of our MTLI seminars.
FOR COMPLETE PROGRAM INFORMATION:
More information can be obtained at:
http://mailiwant.com/links.jsp?linkid=2002&;subid=625344&campid=6380
For questions about the seminar, please e-mail Dia Black at:
dblack@advamed.org
or Betsy Lavin at:
blavin@advamed.org
FOR RECORDED DETAILS BY PHONE:
To hear a recorded message about AdvaMed's upcoming seminars, please call the seminar information line at 202-434-7214.
Sponsored by MTLI.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Nancy Singer
Executive Director, Medical Technology Learning Institute
AdvaMed
1200 G St NW Ste 400
Washington DC USA 20005
202-783-8700 phone
202-783-8750 fax
nsinger@advamed.org
http://www.advamed.org/mtli
http://mailiwant.com/links.jsp?linkid=2003&;subid=625344&campid=6380
Contact: Betsy Lavin
202-434-7235 phone
blavin@advamed.org