Telling Your Medical Device’s Story to Regulatory Agencies

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What does it take to convey a medical device’s value to the FDA or a Notified Body? It takes more than simply focusing on the innovative engineering of the device, or even how the device satisfies an unmet need.

Industry experts with substantial insider experience will likely point toward something else—your ability to tell the device’s story. While regulation is generally viewed as documenting how you are compliant, it also includes explaining how your device came to be and why that matters. Storytelling can be a helpful way to deepen our understanding of what constitutes clear and persuasive regulatory documentation, but only if we know what we mean by it.

Join NAMSA for this webinar as we explore the advice of several experienced regulatory experts and provide pragmatic recommendations on how to tell a good story.

Attendees of this webinar can expect to learn how to:

• Understand the role of qualitative research in storytelling
• Identify how to organize key documents
• Develop practical rhetorical strategies for developing clearer, more compelling storytelling

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