Transferring notified bodies is a critical process and a manufacturer should make this decision carefully. The reasons that medical device manufacturers have for transferring notified bodies can range from a personality conflict with a client manager to the notified body no longer being able to support the manufacturer’s certification. Regardless of the reason, both manufacturers and notified bodies must take into account the guidelines governing this process, and for the manufacturer specially, when choosing which notified body to transfer, how this notified body will fit in with his certification plans.
To help manufacturers learn about the requirements and give them the tools to understand and make this strategic decision, the webinar will explore the following points:
• The reasons to change Notified Body
• The keys points for a manufacturer to consider before making the decision to transfer NB and the prerequisites for transferring
• Introduction to the guidelines & the documents governing the transfer process
• Presentation of the technique for transferring a manufacturer’s notified body
• Changing in the labeling
For the answers to these questions, and more, you can tune to LNE/G-MED North America’s webinar on Transferring notified bodies.