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Addressing the Notified Body Bottleneck

A session by Eric Henry
Sr. Quality Systems & Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

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About this session

Even with the delay in EU MDR and IVDR implementation, designated notified bodies are and will be a scarce resource.

This presentation explores the current state of notified body designation and how companies can navigate existing and anticipated scarcity. There will also be discussion of how notified bodies are operating under COVID-19 restrictions and the impact this may have on availability.

Key Takeaways: - Data and resource links to better understand notified body availability in the early days of EU MDR applicability - Strategies for ensuring timely review of products by notified bodies - An understanding of how COVID-19 impacts notified body availability

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