UDI FDA Compliance
Unique Device Identification (UDI) - It's Official
What do you do now?
We know UDI...with its founding membership in the UDI Committee, a sub-committee of AIM N. A., The Danby Group works diligently with policy makers, Congress, the FDA, and the medical device community and providers. Whether you decide to mark with linear or 2D bar codes, RFID (Radio Frequency ID) tags or both, The Danby Group has the solutions for marking just about anything.
We know marking...with the healthcare industry embracing both laser and image-based scanning technologies. you can leverage the best of the best. And fortunately, regulatory compliance provides a choice of utilizing traditional thermal transfer label printing, C02 laser printing, or marking directly on the item itself; The Danby Group can deliver proven solutions that are best suited for your company's UDI strategy to launch. You'll soon realize more than just compliance - a way to better track assets, inventory, warranties and recalls, and much more.
We know label management...partnering with Innovatum, Inc. (ROBAR and InnoTasc) and Seagull Scientific (Bartender™), Danby provides a centralized enterprise label management system specifically designed for healthcare compliance. Easily track and manage:
- Your company's UDI program, as well as Part 11, GS1, FISMA, GSA and many other regulations
- Electronic Label drawings, revisions, and e-signature approvals with complete audit trails
- Mark validation
- Any label printing process with or without serialization, remotely or onsite
- Track and trace, and product recalls
- Regulatory icons
- Multi-lingual translations
- GUDID data uploads
We know labels....for over 30 years Danby has been supplying labels and tags to its customers who rely on us for high-quality materials, innovative custom designs, and a vast inventory of consumable labeling supplies.
We know data collection....bar code and RFID-based data collection and tracking systems have been at the heart of our business for 30 + years. We provide stand-alone system design and integration to legacy systems for most manufacturing, warehouse, and distribution systems.
The Compliance Trend...The FDA has its' UDI Rule, and the International Medical Device Regulators Forum unveiled its long-awaited plan for device identification, pushing for a “highly interoperable” and harmonized system to globally track medical devices. The release dovetailed with the European Commission’s recommendation for an EU-wide UDI system. Both plans are closely aligned with the FDA’s rule on UDI.
The Next Step....So, like it or not, marking products with a unique identifying code is here to stay, and growing. The Danby Group can help your company make sense of the rules, and implement a 100% compliant solution across your product line with little disruption to your day-to-day operations. No matter which compliance mandates your company must adhere to, there is one place to call: 800-262-2629.
Please see our Resources box to the right for more related information. Our blog page contains several helpful articles on UDI and unique ID technology components. Blog