Global regulatory agencies – such as the US FDA and the European Commission – are enacting strict policies for labeling and registration of medical equipment. This includes devices ranging 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. A single unintentional divergence from regulations carries the potential for penalties and irreparable damage to a company’s reputation and market share.
Medical device manufacturers require labeling and barcode software solutions that are secure, proven and reliable; that fully integrate with existing systems and workflows; and scale and adapt to evolving business practices.
BarTender® software (Professional, Automation and Enterprise) is 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.