Join us for an in-depth webinar designed for medical device manufacturers navigating FDA requirements related to product labeling, traceability, and Unique Device Identification (UDI). Whether you’re preparing your first UDI submission or reassessing your compliance program, this session offers a structured, strategic overview of what the FDA expects—and how to implement it correctly across your device portfolio.
We’ll cover:
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UDI applicability for Class I, II, and III devices
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DI/PI assignment and packaging hierarchy compliance
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FDA labeling standards under 21 CFR Part 801
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Submitting and maintaining records in the GUDID
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Common mistakes that trigger misbranding or enforcement
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Best practices for long-term compliance and audit readiness
Engage directly with our regulatory experts in a live Q&A session and get clarity on the technical and practical challenges of UDI implementation.
