Audio Conference

CE Marking: 7 Steps to Getting Started in Europe Rene van de Zande CEO, Emergo Group Inc. Purchase recording US$199

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With a population approaching a half-billion people, the EU represents arguably the most lucrative market today. However, before any medical device company can sell in Europe, it must first obtain the CE Mark. The process of obtaining approval to affix the CE Mark to your product differs significantly from the US FDA system. This presentation will cover the basic steps companies need to follow in obtaining the CE Mark, including a discussion about ISO 13485:2003 and how it differs from FDA Good Manufacturing Practices (GMP), issues related to language translation and labeling, creation of a Technical File and how this differs from the FDA 510(k) application, dealing with Notified Bodies, selecting an Authorized Representative and an overview of the costs and timelines involved in achieving certification.

This audio conference will address:

• Comparison of ISO 13485:2003 to FDA GMP
• How to hire and work with a Notified Body
• Selecting an Authorized Representative
• Differences between the Technical File and the 510(k)
• Post-market surveillance by Competent Authorities
• Coming changes to the Medical Device Directive (MDD)
• Options for setting up distribution

Speaker biography:

Rene van de Zande is CEO of Emergo Group, one of the leading medical device and IVD consulting firms with more than 380 clients in 29 countries worldwide. Before starting Emergo Group in 1997, he served the international commercial community as Senior Issues Coordinator for the EU Committee of the American Chamber of Commerce in Brussels, Managing Director of the European-American Industrial Council, and Senior Commercial Specialist for the U.S. Foreign Commercial Service in Belgium. Rene received an undergraduate degree from the University of Nijmegen in The Netherlands and a graduate degree from Johns Hopkins University, School for Advanced International Studies (SAIS). He has published numerous articles on CE Marking and medical device regulatory affairs for several national trade publications, and is active in the European Association of Authorized Representatives (EAAR).

Who Should Attend?

• Senior Management
• Regulatory Affairs
• Quality Assurance
• Sales and Marketing
  
  This audio conference is rated General Interest.
  

Purchase Options:

• Purchase a recording of this event US$199