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... Click here to READ MORE!
Topic: Notification of change: How, when and what to communicate with your Notified Body?
Date: Wednesday, March 29th, 2017
Time: 2:00 - 2:30 PM Eastern Standard Time