Tag Archives: Class II medical devices

Are You Ready For FDA UDI Compliance?

Take Our Interactive Assessment and Find Out If You’re Prepared to Meet the September, 24th, 2016 Class II UDI Submission Date

The deadline for Class II Unique Device Identification (UDI) submissions is September 24, 2016.  With only a few short months remaining, companies are faced with the significant challenge of locating tremendous amounts of product data.

The FDA has mandated an effort to improve the identification of medical devices such as blood glucose monitors to scalpels, which is expected to increase standardization, efficiency and most importantly, safety of patients. But, it does place an additional regulatory burden on device manufacturers.

Are you 100% confident that you’re ready for UDI compliance?

Take Our Interactive Assessment!

We Can Help! 1WorldSync Supports Compliance With FDA UDI Regulation
Leverage our experience and world-class solutions to save resources and quickly amplify your profitability. Our connection to the FDA Global Unique Device Identifier Database (GUDID) means that you’ll have trusted, accurate product information to comply with the UDI regulation.
WorldSync’s healthcare offering is a comprehensive solution to capture, manage and share your product information. Our solution empowers manufacturers to:

  • PREPARE product information to be compliant to FDA UDI regulations
  • CAPTURE and aggregate data across multiple countries and markets to ensure compliance with medical device regulations throughout the global supply chain, including International Medical Device Regulatory Forum (IMDRF)
  • MANAGE product information from multiple entry points to ensure complete and accurate information.
  • DISTRIBUTE product information using a timely, manageable and auditable methodology.

Talk To An Expert Today!

Have you started planning for UDI compliance?

Class II and Class I UDI compliance deadlines are rapidly approaching. Does your strategy enable your business for long-term success? As a 1WorldSync customer you can add easily add UDI compliance to your existing subscription. You’re already exchanging trusted, accurate product information with your trading partners – why not use that process to send UDI compliance product information to the FDA?

Join the ranks of leading medical device manufacturers that are leveraging 1WorldSync to implement product information strategies for UDI compliance and beyond. Want to learn more?

Attend our informative webinar, How to Turn UDI into a Competitive Advantage, hosted by 1WorldSync Healthcare Industry Expert Todd Simons and Nada Savatic of Abbott Laboratories. Ready to get started today? Sign up for the 1WorldSync UDI solution or come visit us at Booth #6 at the FDA UDI Conference April 18-19 in Baltimore, MD.

The FDA wants YOU – to be compliant

September 24th 2015 is upon us, thus the second deadline for UDI compliance has arrived. As a quick recap, the FDA is requiring all medical device product information to be submitted to their Global Unique Device Identification Database (GUDID) in order to more easily and accurately identify and trace medical devices along the supply chain. (You can find out more about the regulation and compliance deadlines here.) Continue reading