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In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions.
Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testing for your device. With actionable tips and real-world examples, this discussion highlights how to craft effective, clear, and concise device descriptions that resonate with both reviewers and regulators.
Key TimestampsWhat is a device description?
A section of your regulatory submission detailing what your device is, how it works, and its intended use. It includes:
Why it matters:
Poll Question:
What challenges have you faced in creating a device description?
We value your feedback!
Sponsor:
This episode is brought to you by Greenlight Guru, the only QMS purpose-built for MedTech. Streamline your submissions, ensure compliance, and get to market faster. See how Greenlight Guru can help you.
4.8
9191 ratings
In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions.
Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testing for your device. With actionable tips and real-world examples, this discussion highlights how to craft effective, clear, and concise device descriptions that resonate with both reviewers and regulators.
Key TimestampsWhat is a device description?
A section of your regulatory submission detailing what your device is, how it works, and its intended use. It includes:
Why it matters:
Poll Question:
What challenges have you faced in creating a device description?
We value your feedback!
Sponsor:
This episode is brought to you by Greenlight Guru, the only QMS purpose-built for MedTech. Streamline your submissions, ensure compliance, and get to market faster. See how Greenlight Guru can help you.
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