Lessons Learned: Notified Body Feedback Regarding Client Submissions

Operating room with monitor

Published:

May 28, 2024

In this episode of NAMSA’s MedTech Matters video series, Adrian Keene (Associate Vice President of Global Biological Safety & Validation and EMEA Consulting Services at NAMSA) discusses the process and strategies for addressing Notified Body feedback for successful CE certification. He covers the most important aspects needed in a submission, including clear and descriptive device information, clinical benefits of the device, and the safety and performance objectives. He outlines best practices for Notified Body submissions and then discusses how NAMSA can assist Sponsors with this process.

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