TransPerfect Medical Device Solutions and 121nexus announced an update to the EnCompass system for content automation and distribution. The updated system is designed to cut labeling cost, risk, and turnaround by 50%, identify and eliminate mislabeled products and provide device users with easy access to digital information and direct product ordering.
In September 2016, the FDA’s UDI regulation deadline arrived for the majority of U.S. medical device manufacturers. In response, the industry invested billions of dollars into UDI implementation and compliance. Now, the EnCompass system leverages UDI, combined with patented processes and mobile scanning technology, to deliver cost savings and increased revenue to device makers worldwide.
“Originally, UDI was developed to cut through the complexity of the U.S. device distribution system and facilitate critical recalls. However, as implementation has progressed, it’s become increasingly clear that UDI can and should serve a much larger role. The EnCompass system—including the 121nexus platform—is the first commercial product to deliver on this promise. It’s no exaggeration to say that systems like this are why UDI was created,” said Jay Crowley, former FDA Senior Advisor for UDI, and now VP of UDI at USMD.
Major device makers are leveraging UDI and utilizing the modular EnCompass system to meet vital business requirements:
- Inventory Compliance: UDI scanning app (free download from the iTunes store here) ensures the product is correctly labeled and registered in FDA’s GUDID.
- Direct, Mobile Ordering: UDI scanning app—customized for home or hospital users—integrates with manufacturers’ online ordering system for seamless online sales.
- E-Labeling and E-Marketing: Mobile app delivers point-of-use labeling and easy access to training, testimonial videos, and all other assets that make up product’s “digital dossier”.
- Automate Content Processes: Cut content cost, risk, and turnaround by 50% with XML content management for automated publishing, together with automated translation processing.
TransPerfect Medical Device Solutions
[Want to stay more on top of MDO content? Subscribe to our weekly e-newsletter.]