UDI For Medical Devices

UDI Software For Medical Devices

As initiated by the Food and Drug Administration (FDA) in 2013, a regulatory framework requiring structured product labeling for critical medical devices (beginning with class III devices) using the Unique Device Identification System (UDI) continues to be established. With a range of benefits to industry, FDA, healthcare providers, systems, and consumers, the UDI system represents a standardized identifier that will eventually be recognized around the world. As devices are labeled with an UDI, specific characteristics concerning the device are then submitted to the Global Unique Device Identification Database (GUDID), which serves as a reference catalog for every device with an UDI. In human and machine readable form, the UDI system, when fully implemented, will identify the medical device, increase accuracy in reporting, reduce medical errors, allow for effective management of medical device recalls, and add security to the distribution chain, on a global scale.

HAL Systems, Inc., is fully compliant with the format and requirements for UDI as ruled by the FDA. Our software solutions are specially geared towards small to mid-sized businesses seeking cost-effective solutions that will work with the unique needs of your business. With entry-level to fully functional HAL Traxx Software using barcoding and Radio Frequency Identification (RDIF) technology, we’ll configure a solution that works in your world, driving capability to define and control medical devices by UDI.

Browser Based Software Solutions

When it comes to tracking and traceability, businesses benefit from a browser-based environment, giving invaluable insight to internal and external operations. At HAL Systems, Inc., our software becomes the solution, giving users the ability to access information in real time, anytime. Core software at HAL Systems is hosted in the server, and can work with any hardware device with a browser, including tablets and smartphones.

Enhancing HAL Traxx Inventory and HAL Traxx Assets solutions, HAL Traxx Mobile optimizes management of inventory and assets from fixed to mobile to customer locations. This is a great advantage to any business, especially when it comes to tracking products, devices, or assets that are critical or require special handling.

Whether you are seeking a simplified design or customized interface application, HAL Systems, Inc. will configure an affordable solution for your small to mid-sized business that works the way you want it to, with the features that you need. Contact us today to find out more.