The MPE Degree

A Case Study in UDI Compliance

A Case Study in UDI Compliance

In simple terms, UDI (Unique Device Identifier) is a standardized numbering and traceability system for medical devices. In an earlier post, “UDI Compliance – Is Your Company Ready” we discussed in more detail the specifics of the UDI requirements.

We have assisted many of our customers with their UDI compliance activities and no two have followed the same path. Here is one example of how MPE’s documented process led to a successful implementation of UDI compliant labeling for a large MedTech OEM.

This particular customer has a comprehensive IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) validation process. The purpose is to establish documented evidence that all necessary equipment are present, connected to appropriate utilities, performing to the approved specifications, and demonstrate that the process under normal operating conditions will consistently produce labels in compliance with UDI specifications. After equipment validations were complete several combinations of print parameters were tested in an engineering study to determine optimum print conditions. Capability tests were then performed to verify that the parameters will hold over the long term.

This process took 3 to 4 months to complete, consisted of bi-weekly conference calls and culminated with the customer being on site at MPE for 4 days at the end of the project.

MPE’s quality team can help your company achieve UDI compliance. Whether your organization has a detailed IO, OQ, PQ validation process or something much less stringent, MPE has the expertise you’re looking for.

For more information, please contact the MPE sales department at 800-266-1687 or
[email protected].

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