Spotlight on Clinical Excellence: An Exclusive Q&A with Dr. Amie Smirthwaite

 

What does it take to align device performance, clinical benefits, and regulatory expectations? Dr. Amie Smirthwaite, Senior VP of Scientific Affairs at RQM+, shares her deep expertise in clinical compliance for MDR. Drawing from her extensive background, including her pivotal role at BSI and her contributions to ISO standards, Amie offers actionable insights into what notified bodies prioritize when reviewing clinical evaluations and how manufacturers can avoid common pitfalls.

Dive into this engaging session and empower your regulatory strategies with expert guidance.

Discover how Fern.ai digitalizes and automates the clinical evaluation of medical devices:

Four key innovation drivers enabled by EU MDR

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Driver 1:

Clinical evaluation
workflow automation

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Driver 3:

Systematic post-market
surveillance

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Driver 2:

Streamlined external
collaboration

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Driver 4:

Cross-functional
knowledge sharing

Take a sneak peek

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