Have you ever wondered how the European Directives were made? What does “CE” stand for? Or Why do we call Notified Bodies by this name and what their role is?
Medical device manufacturers that sell their products in Europe need to know the answers to these questions. Notified bodies have many responsibilities that extend beyond simply performing product assessments for CE Marking. Join LNE/G-MED North America in its Free webinar, CE Marking and the Roles of Notified Bodies and learn how the Directives, notified bodies, and CE Marking fit together.
As a leading notified body, LNE/G-MED will answer the following questions:
• What is CE Marking and how does it apply ?
• The role of Notified Bodies and their responsibilities with respect to Manufacturers and the Competent Authorities.
• What is the connection between a Notified Body like LNE/G-MED, medical device manufacturers, European Competent Authorities, and the European market and what is the roles of each when it comes to get a safely performing device to Europe.
Participants will gain an understanding of the role and responsibilities of Notified Bodies in Europe, the process a manufacturer of Medical devices has to comply with in order to obtain CE marking and much more …