Medical
Global regulatory agencies such as the US FDA and the European Commission are enacting strict policies for the labeling and registration of every single piece of medical equipment, from simple tongue depressors to complex life-saving technologies.
With patient safety at the core of these unique device identification (UDI) regulations, there is no room for compromise: Even the smallest unintentional divergence from the rules carries potential penalties and irreparable damage to a company’s reputation and market share.
Medical device manufacturers require labeling solutions that are secure, proven and reliable; that integrate completely with existing systems and workflows; and that can scale and adapt to evolving business practices.
QTE Solutions offers Seagull Scientific BarTender software design and marking software as a secure component of FDA-compliant UDI installations around the world. The medical device industry chooses BarTender for its ease of deployment and configurable technology, all backed by industry expertise — we understand the regulatory and process pressures medical device manufacturers face.
Integration
Seamless integration with ERP systems like Oracle and SAP enables automation at the enterprise level, providing increased labeling accuracy while also improving efficiencies throughout the supply chain.
Control and compliance
Centralized control connects your business data with a wide variety of printers and marking devices — whether you have one device at a single site or thousands at facilities around the world. BarTender provides the secure and audited RFID technologies, including UDI’s HIBCC and GS1 symbologies and EPCglobal Gen2 encodings, that maintain regulatory compliance.
Security
BarTender helps meet the security demands of UDI, providing full audit trail capabilities throughout the entire labeling process. Printer-based licensing and layers of customizable settings add broad protections, with security features ranging from simple print-only settings to complex role-based permissions and label format encryption.
Flexibility
Regulatory and production landscapes will continue to change, and BarTender’s Intelligent TemplatesTM enable you to rapidly transform your designs, formats and processes, with support for meeting evolving interoperability standards through HL7-based UDI database (GUDID) communication.
