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?
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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.