UDI Solutions

Medical devices companies have to ensure FDA compliance within specified dates for tracking certain classes of devices across its product life cycle. Certain information such as Unique Device Identifier for the product have to be submitted to GUDID.

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SCONCE provides a comprehensive solution for Medical Devices manufacturing companies using Windchill UDI and custom solutions. We engage with the customer early in the process and develop a solution with solid foundation that will address the requirements for the next few years.

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Refer to the compliance requirements from FDA here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

Ensuring Success

It starts with the humble mindset to deliver solution that has end-to-end perspective but focused on doing every step right and do that from the beginning.

Our approach is to follow a strong process with detail list of steps carefully laid out to achieve the milestones & business objective in phases.


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