Audio Conference

Industry Update: Vigilance for Medical Devices Rene van de Zande CEO, Emergo Group Inc. Purchase recording US$199

Register for this Audio Conference

After a few quiet years, several important European regulatory changes have occurred or will occur in 2007 that will affect most medical device manufacturers. Most notably, Competent Authorities are now expecting manufacturers to have a good understanding of post-market surveillance, including vigilance. Notified Bodies and Competent Authorities alike are starting to make this a key element of their inspections and companies must be prepared. In this presentation, Rene van de Zande will discuss important new revisions to MEDDEV 2.12-1 rev 5, Guidelines on a medical devices vigilance system, soon to be published in its final form.

This audio conference will address:

• Differences between revision 4 (2001) and revision 5 (2007)
• Adverse event reporting requirements
• Field safety corrective actions
• New items: periodic summary reporting and trend reporting
• New "event" reporting requirements
• What constitutes "user error" and "abnormal use"

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