UDI requirements for class 3 and class 2 devices are now behind you, but the compliance standards continue to emerge and you must maintain the ones you have already completed. Maybe your organization is impacted by all three (3) UDI class distinctions, or MDR (European UDI) standards, or you have additional requirements to maintain these standards.
Medical device companies continue to struggle with the compliance mandates due to the level of commitment to maintain compliance and the demands on their internal resources. Those demands compete for internal resources, creating decisions on which projects to apply resources. These decisions are critical to your business operations.
The Solution …
To maintain compliance for emerging standards and to meet the deadlines for UDI and MDR, organizations have leveraged Pragmatyxs professional resources to supplement or replace their own internal teams, allowing those resources to address other projects in their organization while leveraging the UDI experience. Pragmatyxs consultants have acquired for architecting compliance solutions, for converting labels and for maintaining GUDID databases to the UDI standards.
Key elements in this approach
- Effective resource management to address all corporate IT projects and remain compliant to UDI standards
- Develop standards for UDI compliance throughout your organization.
- Preparation for new compliance initiatives.