The identification and management of medical devices is crucial for ensuring transparency and security in the product flow. WhaleTeq not only provides testing equipment to meet the needs of R&D, production, and after-sales service, but also launches UDiBar—labeling software designed specifically for medical device manufacturers. This software helps you effectively manage product identification information before and after the market launch, making it easy to design and print UDI-compliant labels.

Since 2020, the US FDA has mandated the use of UDI (Unique Device Identification) for medical devices imported into the US. The EU and other countries are also gradually implementing UDI regulations, enhancing product traceability and security throughout the supply chain and accelerating traceability, recalls, and issue tracing.

UDiBar allows medical device manufacturers to design, manage versions, and track printing records for UDI labels in a highly intuitive and streamlined manner. The software's functionality also complies with UDI regulations and traceability requirements, helping companies establish robust, low-risk compliance processes and reducing the risk of errors and rework due to oversight.

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Compliant with the Requirements of ISO13485

 

• Automatically records all operation history, complying with ISO13485 requirements for information traceability, facilitating auditability and risk management.
• Built-in ISO-compliant medical icons can be directly applied to UDI label designs, improving label consistency and legibility.
• Quickly find the corresponding UDI number and label base image for a product, improving printing accuracy and efficiency.
• Provides a software validation report (V&V Report) to assist users with internal audits and system verification.

Allow Multiple Connections to UDiBar Database for Team Collaboration

• Supports user permission control, able to assign label editing and printing permissions based on different roles to ensure information accuracy and security.
• Single authorization, no upper limit on the number of accounts, multiple computers in the same area network can work together to improve work efficiency