Working with Unique Device Identification
The Unique Device Identification (UDI) module allows users to comply with the Part 830 medical device regulation for the UDI submission process. Users can electronically submit unique device identifiers for their medical devices and device packages to the Food and Drug Administration (FDA) Global Unique Device Identification Database (GUDID).
The UDI feature in Windchill allows users to do the following:
• Create, edit, and review their UDIs
• Generate Health Level 7 (HL7) documents populated with UDI information
• Submit UDIs to the FDA GUDID database through an electronic gateway
• Manage and monitor UDI electronic submissions, including history and follow-ups
Creating UDIs
UDIs can be added to Windchill in two ways:
• Created in Windchill
• Imported from a spreadsheet
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• Importing new UDIs from a spreadsheet is not supported for UDI super set.
• UDIs can be created independently, without being associated with a part.
• A UDI can only be linked to one part in Windchill; however, a single part can be associated with multiple UDIs.
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