Second UDI Compliance

GAMP validated. 21 CFR Part 11 compliant. Commitment to UDI Compliance.

The adoption of UDI policies around the world presents a major challenge for global manufacturers trying to understand and comply with this flurry of regulations. In addition, manufacturers are presented with the challenge of submitting UDI data to a myriad of country-specific regulatory agencies, each with their variation to this standard.

Trying to build, configure and maintain individual “connectors” for each country that will support the local attribute definitions, code value lists, and validation rules will be costly and not a scalable solution in the long-term.

Innovit’s UDI Compliance solutions solve these challenges by allowing device manufacturers to implement a “global system and unified process” that is fully integrated with internal systems to submit product data for multiple UDI recipients simultaneously. ◼

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