The identification and management of medical device is a very important part of controlling product flow and safety. WhaleTeq's test device meet the different testing needs of manufacturers in the R&D, production line and after-sales stages, while UDiBar- Medical Device Labeling Management Software can effectively control production identification information of medical devices before and after they are launched on the market.

From 2020, FDA has mandated that medical devices exported to the United States from all countries must introduce the Unique Device Identification (UDI) system; EU followed up in the same year and fully implemented the new regulations to strengthen the control of medical devices. At the same time, countries around the world have also successively announced the UDI introduction schedule. 

The purpose of UDI is to improve the safety and traceability of medical devices within the supply chain, to more quickly identify affected products when recalls or adverse events occur, to investigate the causes of product problems and to monitor product performance and safety.

In response to global medical device manufacturers' needs for UDI label production, printing, and UDI management, UDiBar can assist medical device manufacturers in completing UDI compliance label production, printing, and UDI management in the most convenient way. It can also meet the traceability requirements of UDI and ISO13485 quality management system. In addition, to reduce the burden on regulatory personnel, UDiBar also has the advantage of updating regulations at any time to avoid misjudgments caused by human errors.

Functions

• UDI Encoding and Labeling
  UDI encoding and label editing can be easily completed on a single page, and different packaging levels are displayed in a tree diagram. Built-in ISO medical device icons and support various kinds of barcode output
• UDI Label Printing
  Print UDI compliance labels, export label images and export printing package files
• UDI Database Management
  Use keywords to quickly query UDI related information and print records
• Flexible Configuration of Database Backup
  Set off-site backup within the regional network and select different backup frequencies of days/weeks/months
• UDI Barcode Check
  Scan the barcode to verify it matches the record in the UDiBar database
• Inventory Management
  Batch inbound and outbound management to ensure efficient inventory control
   

Highlights

Compliant with the Requirements of ISO13485

 

• Separate user permissions and properly save the operation history, complying with the data traceability required by the ISO13485 to avoid human errors.
• Built-in medical icons that comply with ISO standards and can be used in UDI label editing
• Provide UDiBar to import ISO13485 quality system related documents, including software validation reports, second, third and fourth level related documents and IQ/OQ/PQ forms

Allow multiple connections to UDiBar database for team collaboration

• Single authorization, no upper limit on the number of accounts, multiple computers in the same area network can work together to improve work efficiency

 

UDiBar database can be converted and exported into multi-national medical database format EXCEL file

Case Study

• Medical Device Startup - Easy UDI Implementation for Global Market Entry