Device direct marking, labeling plan (device and packaging), barcode creation, and GUDID web interfaces
UDI Consulting
GUDID Implementation
Proprietary project management methodology with Data Elements table review, data gathering assistance, and device data submission.
Training
Customized GUDID training unique to your needs that includes UDI documentation for staff training and succession planning.
Global Unique Device Identification Database (GUDID) Services
GUDID is a database administered by the FDA and is a component of the Unique Device Identification (UDI) Final Rule that will serve as a reference catalog for every device with a unique identifier. Synchcor will guide you through the entire process to ensure GUDID compliance.
At Synchcor, we provide consulting and implementation services that includes device classification assessment. Not sure if your devices are excepted from UDI compliance, we can help you find out? By conducting research on your behalf, we verify your device standing with the FDA. Our research includes confirmations with citations that support your particular devices.
Our GUDID consulting services include a readiness assessment to ensure compliance. We navigate you, our client, through the compliance process with a project management methodology developed by Synchcor.
A successful implementation plan is key to GUDID compliance. We assist you the entire way from data gathering, submission of device data into the web interface, to the confirmation of its completeness and compliance.
Our customized GUDID training is uniquely designed to meet your specific needs which includes comprehensive documentation of your UDI program.
