Since the inception of the FDA mandate, PPM has invested in knowledge building and process development to ensure we would be prepared to support our OEM’s compliance requirements when they were ready. During this time, we’ve experienced the many challenges and unforeseen issues associated with implementing a UDI mark or human-readable code. We can confidently say that we have mastered the process.
The approach for delivery systems and implant applications are quite different. On the implant side, for example, a UDI can be marked on multiple substrates, finishes and geometry locations which causes difficulty in verification. This is where PPM engineering, customer project management, and collaboration is essential. Solutions must be customized to meet the individual needs of an OEM. From code generation, 2D matrix verification utilizing ISO compliant verification methods, stats to reporting, PPM has the experience and resources necessary to create an entirely integrated turnkey process supporting manufacturing lead times and supply chain management.