We accompany your way to global UDI compliance

Where are you on your UDI Journey?

For large and medium enterprises delivering their medical devices into many markets, the initial UDI establishment project or expansion beyond US FDA is only the first step in a UDI journey that we expect to last until 2025. This is why it is important to find the right partner for this journey, one who can provide you with a strategic UDI solution and the experience from numerous implementation projects.
The journey of UDI concerns not only one market, but usually several and this is why enterprises need the right partner for a strategic UDI solution.

Transition projects to UDI program

A strategic UDI program, implementing a flexible framework for multiple agencies is necessary for UDI compliance.

Implementation strategy of the UDI Platform

Business

Within the Business stream, we start with a UDI requirements analysis. During this phase, we evaluate your established processes, analyze your requirements with regard to EU MDR, FDA and upcoming regulations. In addition to the technical system landscape, we examine your existing master data status in order to see what is missing in your organization.

All results form the basis for the Business Design phase, in which the To-be-processes for UDI related data governance are designed to the needs of your organization and, if necessary, the organizational change management is triggered. The main focus lies on the definition of the master data strategy for the future in accordance with the To-be-architecture.

Technical/Integration

Based on this Blueprint, the Technical Design can be tackled within the Technical/Integration stream. The workflows are designed to match your process design, the user interfaces are tailored to the needs of your business users, and the data interfaces to your ERP – often SAP-driven – are designed according to the existing technical IT setup. An important step is the user, role and authorization concept, while our solution is usually integrated into your existing Identity Management System.

After we have provided the UDI Platform in the actual implementation phase, the previously designed configuration steps are conducted. The test phase includes functional tests, integration tests and finally the User Acceptance Test (UAT).

Support

In addition to the implementation and testing phase, we offer end-user and IT trainings to prepare a successful experience for your users. After a successful Go-live, we usually plan a Hypercare phase to ensure a smooth transition to your operations. The Hypercare phase is followed by various support activities within our managed service approach to help you maintain continuous compliance.

Our Partners