UDI Label Printing Compliance Inspection System
This system is a full-process solution specifically designed for medical device companies. UDI The compliance solution integrates label printing, quality inspection, data management, and compliance verification into a single platform, ensuring that enterprises fully meet the National Medical Products Administration’s regulatory requirements for unique device identification of medical devices.
Core functional modules
1、 Smart Print Management
Support GS1-DataMatrix、 QR Codes and various other types UDI Code system
Compatible with thermal transfer / Thermal printing technology
Automatically associate product identifiers (DI) And production marking (PI)
2、 Online Quality Inspection
Integrated high-resolution visual inspection system
Real-time verification UDI Print quality of the code, data accuracy, and readability
Automatically classify and remove non-conforming labels.
3、 Compliance Data Management
Built-in National Medical Products Administration UDI Database integration interface
Automatically generate the complete UDI Implementation Records and Reporting
Supports data archiving and audit trails.
Technological Advantages
Printing accuracy reaches 600dpi Ensure the minimum label is clear and legible.
Detection speed can be as high as 200 Envelopes / minute
Support and ERP 、 MES Seamless system integration
Compliant FDA 、 NMPA 、 MDR Pending global major regulatory requirements
Application value
This system has successfully helped numerous... Hundred A home medical device manufacturer achieves UDI Compliance implementation, on average, shortens the compliance preparation cycle. 60% Reduce the cost of manual inspection. 85% , ensure the product 100% Compliant UDI Regulations require providing technical assurance for global market access of medical devices.
Relevant Cases