The FDA’s Unique Device Identification (UDI) regulation may appear less complex when compared to other government compliance regulations. The ultimate objective of UDI is straightforward. The data structures are robust yet intuitive. The approach to compliance is logical
However, like many standards issued by the government, UDI was engineered to be applied to a broad range of unique circumstances. Incorporating your own situation into these requirements is not a straightforward process. Once you delve into the details, the complexities of implementation become apparent.
For instance, large medical devices companies often grow through acquisitions or mergers, which can result in multiple forms of device identification being perpetuated within a single company. UDI has specific deadlines and non-compliance penalties that push companies to adopt a cohesive, uniform labeling system that will be standardized across all companies, and resolve many safety concerns.
This is only one of the roadblocks that lie between companies and UDI compliance. In order to assist organizations in transforming their device labeling systems and reach compliance, Pacific Data Integrators (PDI) has developed UDI-specific services and cloud software and is hosting a multi-tenant UDI MDM Cloud SaaS application.
Through our work in helping organizations transform ‘round’ data holes into ‘square’ data pegs, we have created an application to assist you with profiling, visualizing, changing, and managing your UDI data without upsetting your existing systems and workflow.
PDI's UDI Data Manager serves as a purpose-built UDI staging area for exchanging information with the three UDI issuing agencies - GS1, HIBCC, and ICCBBA. It helps profile, conform, and resolve issues around cross-organizational resolution with Global Medical Device Nomenclature codes. Additionally, this cloud service will help coordinate your device identifications (DI's) and product identifiers (PI's) back to your Product MDM system in an efficient and visual manner.
The UDI Data Manager comes pre-packaged with a daily-updated GUDID database. You can leverage integrated data-profiling capabilities and other tools to serve as a coordinating workspace with the natural ability to export and import data.
By working with our multi-tenant cloud UDI MDM application, you will be able to see existing up-to-date GUDID data and up-to-date GMDN codes. Our application also gives you the ability to incorporate, modify, manage, and then coordinate your data between the FDA, ICCBCC or DISC systems and your own official product master data and labeling systems. With UDI management visibility already in place, you can accomplish these tasks on an aggressive timeline.
