12 Steps for Medical Device UDI Submissions to the FDA GUDID
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- Опубліковано 16 жов 2024
- UDI regulations kick in for Implantables and Class II devices in 2015.
Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields - including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID guidance, e.g., convenience kits and implants
• Notes in setting up a FDA GUDID account
RELEVANT FOR:
• UDI Team Leaders/Members
• Regulatory Directors/Managers/Staff
• Manufacturing, Operations, and Supply Chain Logistics Personnel
• UDI IT Support Personnel
• Compliance Officers
• Distributors with UDI Submission Responsibilities