The company is a leader in devices for spinal surgery serving global markets
UDI compliance project increases productivity
An international medical device company needed to upgrade their labelling processes to meet comply with the UDI deadline for Class II devices.
Problem
The main issue was to find a way to design and print multilingual UDI labels from their non-unicode based SAP system. This solution had to integrate with their SAP ECM (Enterprise Content Management) system and adhere to FDA CFR 21 part 11 regulations.
Solution
The company replaces its disparate labelling systems with a NiceLabel Label Management System (LMS).
They take advantage of the unique LMS “configure-don’t-code” approach to respond to customer requests and regulatory changes. No more lengthy development cycles.
All label data is accessed directly from SAP, eliminating manual duplication and errors..
The company introduced NiceLabel LMS to meet the requirements for UDI. .
Results:
- Multi-lingual and UDI compliant labels
- Hundreds less label templates
- Faster label design and approval process
- Reduced production setup and downtime
- Reduced product mislabelling
- Lower IT maintenance costs
