September 24th, 2020 for Class I UDI compliance is just a heartbeat away, particularly when evaluating the scope of the UDI initiative and the breadth of products impacting your company.
Many suppliers that have previously submitted Class III and Class II product data have already begun gathering and sending Class I data.
Key Challenges for UDI Labelers:
- Understanding the complexities of the UDI legislation as it applies to your organization’s products.
- Finding the existing data, creating data that does not exist, and organizing the data into a single point of truth for submission to the FDA GUDID.
- Setting up the proper data governance to ensure that the information is correct to meet the deadline and continues to stay up-to-date and accurate in the future.
How 1WorldSync Can Help You
- Understanding Rules – Our experts are well versed in the UDI legislation, definitions, and terminology to be able to help your organization identify attributes relevant for UDI per the legislation.
- Data Collection – Our organization has vast experience with previous UDI customers and can provide education and guidance around attribution. In addition, we can also leverage previous knowledge to directionally aid in the sourcing of attribution. Read our new case study to learn how Teleflex partnered with us to implement a data management solution to comply with the upcoming UDI regulation.
- Data Governance – Our team can provide the structure necessary to ensure that information stays up-to-date and accurate, integrating the data collection into day-to-day processes and reducing effort in the future.
Getting To Good Data in the GUDID With 1WorldSync
The general structure of a UDI project is very similar to a typical supplier implementation, with some key exceptions. At the end of the day, data needs to be sent by the supplier to a recipient. 1WorldSync handles this use case on a daily basis and we can provide insight as to proven best practices and strategies.
There are key differences in a UDI project that our experts are trained to guide you through. These key differences include applying for a GUDID account, testing with the FDA, and understanding FDA specific attribution.
Whether your organization relies on a HIBC or a GTIN (or you’re looking for definitions on what those terms mean), 1WorldSync offers multiple solutions to send your data to the FDA. A primary benefit of submitting data through a 1WorldSync solution is that the data collected can be easily sent to other recipients, including GPOs, distributors, and other healthcare providers.
Generating Value Beyond Compliance with 1WorldSync
The amount of time and effort to prepare for compliance with the FDA UDI regulation is frequently underestimated. Your organization may need to start sooner than you think.
If you’re like us, you like to be ahead of the game. With the 1WorldSync UDI Solution, your business can prepare and validate medical device product information before the compliance deadline, giving you more time to focus on producing the quality products your customers and patients love.
Make plans to stop by 1WorldSync (Booth # 6) at the UDI Conference taking place June 7-8 in Baltimore. Learn UDI implementation strategies and identify a sustainable process to successfully publish product content to the GUDID from our experts first-hand!
For more information around our offerings and experience, please contact us at firstname.lastname@example.org or visit http://solutions.1worldsync.com/-unique-device-identification.