The Instructions for Use (IFU/eIFU) for a medical device or pharmaceutical product are considered part of the product and a critical part of labeling process. While all regulatory agencies require certain information such as step-by-step instructions and use-by-dates on all IFU documents, other required content can vary significantly by region, making the management and production of these documents a complex and time-consuming process. The regulators who approve these documents may also set limits on factors like fonts and font sizes, visuals, spacing and colors used. Any change to an approved IFU must be re-evaluated for approval.
Managing content and their translations, maintaining version control and integrating source data with label printing and output capabilities are critical functions in the production of Instructions for Use. Loftware solutions help you manage IFU and eIFU production and distribution more effectively by enabling you to:
