Instructions for Use | Labeling for Medical Devices
Medical Technology companies dedicate an immense amount of resources to ensure that they meet the minimum labeling requirements for medical devices. The content contained on device labels is often replicated across numerous labeling documents. This results in a huge volume of highly complex labeling content which is difficult to create and manage. There is significant risk of errors and omissions that can only be overcome with complex processes and people. These issues are compounded by strict and evolving rules for submitting labeling content to the FDA and EMA.
Author-it Labeling for Medical Technology companies utilize a component-based approach to re-using content for the creation and management of labeling documentation. Author-it is the modern successor to outdated document based or complex XML systems.
Facilitating re-use and single source production of labeling for medical devices, Author-it produces to any output be it print or online. By improving efficiency while reducing risk of errors and omissions, the result is ensured regulatory compliance, faster time-to-market and increased patient safety.
- Ensure Compliance Simplify overall review cycles with a clear audit trail, reducing regulatory risk and ensuring content consistency across multiple channels.
- Faster time-to-market Reduce time-to-market when labels are fast tracked by streamlining documentation processes.
- Increased automation Manage documentation efficiently by using automated workflows, templates, and branding.
- Improve patient safety Be certain the information provided is accurate and up-to-date to ensure patients understanding.
If you're ready to learn more, view one of our Case Studies and Webinars, or request a consultation to discuss if this solution is right for you.
Consumer: Medical Device Manufacturer
Agile Life Sciences Content with Ann Rockley
Technology: Global Manufacturing and Technology Company