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Production environment software UDiBarmanagementdata managementreporting
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Characteristics
- Applications
- production environment
- Function
- management, data management, reporting, traceability, data tracking, barcode label, validation, verification
- Certifications
- ISO
- Other characteristics
- automated
Description
Overview
Implementing UDI (Unique Device Identification) is a critical requirement for medical device manufacturers. Many organizations still manage UDI data using spreadsheets and manual cross-department processes, which increases the risk of errors and complicates compliance with ISO 13485 and QMS traceability requirements.
One-stop digital management for rapid UDI implementation
UDiBar centralizes production and label workflows to establish UDI management processes aligned with medical device regulations. UDiBar automatically generates standard-compliant UDI barcodes (supports formats such as EAN-13 and GS1-128) to ensure consistent, standards-based labeling.
Key features
Regulatory & compliance
UDiBar supports documentation and traceability practices required by ISO 13485 and common medical device regulations. The included V&V report helps demonstrate validation of label-related processes.
Target users
UDiBar is a label management software developed by WhaleTeq for medical device manufacturers and contract manufacturers (CMOs) seeking to standardize UDI workflows and strengthen quality management.
Technical specifications
Implementing UDI (Unique Device Identification) is a critical requirement for medical device manufacturers. Many organizations still manage UDI data using spreadsheets and manual cross-department processes, which increases the risk of errors and complicates compliance with ISO 13485 and QMS traceability requirements.
One-stop digital management for rapid UDI implementation
UDiBar centralizes production and label workflows to establish UDI management processes aligned with medical device regulations. UDiBar automatically generates standard-compliant UDI barcodes (supports formats such as EAN-13 and GS1-128) to ensure consistent, standards-based labeling.
Key features
- Automatic generation of UDI barcodes compliant with international standards (EAN-13, GS1-128)
- Management of UDI production records and label printing history
- Hierarchical label management and version control to track label changes
- Fast search for UDI numbers and associated label templates to improve operational efficiency
- Built-in database with full traceability mechanisms
- Includes a Verification & Validation (V&V) report to support regulatory submissions
Regulatory & compliance
UDiBar supports documentation and traceability practices required by ISO 13485 and common medical device regulations. The included V&V report helps demonstrate validation of label-related processes.
Target users
UDiBar is a label management software developed by WhaleTeq for medical device manufacturers and contract manufacturers (CMOs) seeking to standardize UDI workflows and strengthen quality management.
Technical specifications
- Product name: UDiBar
- Developer / Brand: WhaleTeq
- Purpose: UDI and label management for medical devices
- Key functions: UDI barcode generation, production management integration, label printing records, hierarchical label management, version control, fast UDI search
- Supported barcode formats: EAN-13, GS1-128
- Data management: built-in database and traceability mechanism
- Compliance support: Verification & Validation (V&V) report; supports ISO 13485 and QMS traceability requirements
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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.