Industry Webinar: Medical Device Registration in the European Union

Location / Date: your computer - Tuesday, February 9, 2010 - 12:00 noon EDT                           

Event Summary:
Join the U.S. Commercial Service for a comprehensive review of the regulatory approval process in the European Union for medical devices.  Marc-Henri Winter, Technical Director of LNE-GMED, will share his experience in processing EU registration for American companies.  Marjorie Cote, QA/QR Director of Pulpdent, will present on her experience as a small American company entering the EU market.
 
Webinar Overview:
How do I register my product in the EU?
Can my in-country distributor help with the regulatory approval process?
Does it matter which country is approached first for classification?
What are other companies doing to be successful in these markets?
How much does it cost?
 
Scope
Registration process from CE marking to market access for medical devices, medical equipment, instruments and disposables as well as dental equipment and supplies will be addressed.  Diagnostics and pharmaceuticals will not be included in this overview.
 
Presenters
Marc-Henri Winter, Technical Director, LNE-GMED
Testimonial: Marjorie Cote, QA/RA Director, Pulpdent
 
Registration Fee
$95 per person

Registration Link
http://www.buyusa.gov/healthcare/eu_registration.html
 
Contacts
Pompeya Lambrecht
pompeya.lambrecht@mail.doc.gov
Tel.: 602.277.5223

Rochelle Williams
rochelle.williams@mail.doc.gov  
Tel.: 619.557.5899