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Global Unique Device Identification Database (GUDID) Services
GUDID is a database administered by the FDA that will serve as a reference catalog for every device with a unique identifier. Haskins Advisory Group provides guidance through the entire infrastructure setup. We design and document the ongoing process for modifications and new device GUDID compliance.
1. Customized GUDID requirements training: select issuing agency, direct marking, labeling plan (DI, AIDC technology), attributes, technology, and timeline.
2. Consulting Services: Assessment of current state and design infrastructure to meet GUDID compliance.
a. Assist in submission method determination
b. Account setups
2. Electronic Submission Gateway (ESG)
3. Applicability Statement (AS2)
c. Identify attribute requirements
d. Map attributes from existing databases
e. Convert attributes to XML
f. Test connection
g. Send formatted XML files via HL7/SPL
h. Verify successful test
i. Establish production connection
j. Send production XML files
k. Verify successful production load
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