Starting with the US FDA, medical device regulators are instituting Unique Device Identification (UDI) compliance requirements in regional markets around the world. Staying compliant can be viewed as both a challenge and an opportunity to institute a more robust regulatory management process. Leading manufacturers are leveraging the digital thread gateway to submit UDI data in a more sustainable fashion, which streamlines validation and centralizes UDI product data for a shared, global view into submissions to health authorities.
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