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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.

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
  • FAQ

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Certification Project Manager - In Vitro Diagnostics responsible for medical device manufacturing clients.