Establishing UDI is the most important task for medical device manufacturers at present. However, there is no system on the market that can manage UDI digitally. Manufacturers need to gather relevant departments to spend a lot of time discussing and formulating processes and forms. Using Excel can't meet the traceability and management requirements of ISO13485 / QMS, and there is also a risk of typos and data missing.
UDiBar- UDI generator and label management system can quickly solve the above-mentioned problems. UDiBar not only conforms to the world's trend of digitalization, but also integrates UDI regulatory requirements, helping users to complete UDI editing and create compliant barcodes effectively. Users can design and edit label base maps. By using a database, users can also manage and track production barcodes efficiently, transferring the data to a format that conforms to the national medical database. This system can also be combined with ERP to effectively reduce labor costs.
Item | Specification |
---|---|
Operating system |
Windows PC (Microsoft Windows 10 64bits, Original version is recommended) |
Supported software |
Microsoft .Net Framework 4.5 to latest version |
Hardware space |
1GB RAM or bigger |
Memory |
1.5 GHz CPU or bigger |
Data storage |
Saved on the local side |
Database |
MySQL Community 8.0 |
Product information set-up |
UDI Management System |
Data update |
Updates product information regularly either automatically or manually |
Internet |
Needed only when updating product information |
Output file format |
CSV file |
Backup |
Backup manually or automatically on a regular basis |
Printer |
All Windows Driver printers supported |
Language |
Traditional Chinese, Simplified Chinese, English |
Database conversion format |
GUDID:HL7 file NMPA:Excel file TUDID:Excel file EUDAMED:XML file |
User Account support |
Limitless |
Automation system support |
API |
External system support |
ERP system integration |