Medical device labeling

Manage the complexity of your labeling and packaging artwork with Loftware. Loftware Spectrum for Medical Device offers pre-configured, built-in applications that automate common labeling operations and enable compliance with regulations such as 21 CFR Part 11, EU MDR and FDA UDI. Spectrum provides you with dynamic fields that adapt automatically to variable content and allows you to share label templates across product SKUs, reducing the time to maintain and validate labels.

Loftware solutions also manage content for cautionary statements, translated phrases and other shared content that appear on labels, IFUs and other ancillary documentation. With their advanced capabilities, you can also solve many of challenges inherent in managing IFU/eIFU documents, patient inserts and packaging artwork for medical device products.

Loftware solutions help you increase the accuracy and consistency of labeling and packaging artwork processes by:

• Aiding in compliance with regulations such as 21 CFR Part 11 by including e-Signature with comment requirements in label printing and reporting applications
• Shortening the time to create and update labels with advanced label design capabilities that include the ability to use live data from sources of record, commonly used symbols
• Improving accuracy and efficiency with pre-configured applications that guide users through common labeling processes specific to medical device manufacturers
• Printing to multi-label layouts often used in medical device packaging
• Providing full tracking of edits and approvals of label changes, labels printed and other processes
• Eliminating the need for inefficient, error-prone data duplication with integration with systems of record
• Enabling efficient, data-driven on-demand label printing to support kitting processes