Join us on Wednesday, March 29th at 2:00 pm EDT as LNE/G-MED North America Inc. will be hosting a free informative session on Notification of changes: How, what and when to communicate with your Notified Body?
Innovation triggers changes. The Medical Device Industry more than any other industry, follows the course of demands and needs that see thousands of technologies transform through the years, devices evolving into new generations of products. Those changes can either be features added to answer a specific design challenge or a simple evolution to enhance the usability of the device to benefit patient(s) or end user(s). Changes can also be linked to the company’s situation: site relocation or expansion, a change in critical supplier(s) or a merger/acquisition.
Before operating a change, manufacturers need to understand the impact with regards to the regulations and applicable standards; and how this change will reflect on the device or company’s certification. The company needs to evaluate the extent of this change on its daily operations, by anticipating its impact on its upcoming audit. Significant changes for example need to be evaluated by your Notified Body prior to their implementation to confirm if any additional evaluations are needed to maintain the device /Quality System conformity.
Join LNE/G-MED and Ehab Amen, Production Director, for an introduction on Notification of changes and submit your questions for this webinar by March 15th, 2017.
Ehab will touch on some of the common changes, the ideal timelines in which those changes should be presented to your Notified Body, what would normally be expected from a medical device manufacturer to prepare and the does and don’ts during the change notice submission process.
In this webinar, you will learn about:
- Definition of change notice (significant change, minor change etc.)
- Common scenarios of change notices (relocation, extension within scope, design change, transition to new standard etc.)
- Ideal timelines for communication of change notice to your Notified Body
Topic: Notification of change: How, when and what to communicate with your Notified Body?
Presenter: Ehab Amen, Production Director for LNE/G-MED North America, Inc.